Takeda Pharmaceutical Jobs (24)

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use .

I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role :

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.

By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.

Join Takeda as a Director, of Global Regulatory Affairs CMC where you will oversee the development and execution of regulatory CMC development and registration strategies.

You may manage staff members. As part of the Global Regulatory Affairs CMC team, you will work with Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff.

How you will contribute :

Demonstrate Takeda leadership behaviors.

Independently manage regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities.

Participate in global teams that require experienced interpretation of applicable EMA / FDA / ICH / WHO / Global regulations to ensure CMC compliance.

Evaluate change proposals for regulatory impact and filing requirements.

Lead team members that establish CMC content (data and documentation) requirements for regulatory submissions and will review this content for conformance with established requirements.

Lead and contribute to business process development.

Evaluate new business development opportunities or represent Global Regulatory Affairs CMC on due diligence teams.

Maintain constructive relations with essential colleagues, e.g. colleagues within Takeda, Alliance Partners, and Health Authority representatives.

Ensure that project team colleagues, line management, and partners are informed of developments that may affect regulatory success.

Elevate and communicate actual or potential issues to line management.

Successfully communicate and negotiate with international Health Authorities, directly and indirectly.

Represent Takeda Global Regulatory Affairs CMC in Health Authority meetings and lead CMC preparation activities for meetings with Health Authorities on CMC-related matters.

Manage and support staff, if required, including staff professional development and project oversight.

What you bring to Takeda :

BS / BA Degree in a Scientific Discipline, Advanced Degree preferred.

10+ years of pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience, with international experience strongly preferred.

Experience liaising with Regulatory Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred.

Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.

Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams.

Ability to deal with issues of critical importance provides regulatory advice and makes reasoned decisions on regulatory issues for which there may not be clear / specific regulatory guidance.

Demonstrated leadership, problem-solving ability, flexibility, and teamwork.

Good judgment in elevating and communicating actual or potential issues to line management.

Excellent written and oral communication skills.

Experience of active participation in Agency / Industry groups / forums expected.

Travel Requirements :

Willingness to travel to various meetings, including overnight trips.

Requires approximately up to 10-30% travel.

This position is currently classified as hybrid in accordance with Takeda’s Hybrid and Remote Work policy.

Base Salary Range : $156,800 to $224,000 based on the candidate's professional experience level. Employees may also be eligible for Short-Term and Long-Term Incentive benefits as well.

Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

What Takeda can offer you :

Comprehensive Healthcare : Medical, Dental, and Vision

Financial Planning & Stability : 401(k) with company match and Annual Retirement Contribution Plan

Health & Wellness programs including onsite flu shots and health screenings

Generous time off for vacation and the option to purchase additional vacation days

Community Outreach Programs and a company match of charitable contributions

Family Planning Support

Flexible Work Paths

Tuition reimbursement

More about us :

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs.

Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.

We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine :

Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

LI-LC1

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use .

I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role :

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.

By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Senior Data Engineer where you will lead the implementation of development, testing, automation tools and IT infrastructure in line with SDLC principles and leading implementation of DevOps through the entire architecture.

You will report to the Head, Digital Platforms and Manufacturing Informatics Cell Therapy and will be a part of the Cell Therapy Engineering and Automation team.

How you will contribute :

Lead the implementation of various development, testing, automation tools and IT infrastructure in line with SDLC principles and leading implementation of DevOps through the entire architecture.

Specifically, lead continuous improvement and build continuous integration, development, and constant deployment pipelines.

Write code to develop and test the required solution and architecture features to enable seamless data pipelining and flow to many different end-applications such as front-end visualization platform, Tableau dashboards etc.

Test the code using the appropriate testing approach. Deploys software to production servers. Contributes code documentation, maintains playbooks, and provides timely progress updates

Define relational tables, primary and foreign keys, and stored procedures to create a data model structure. Evaluates existing data models and physical databases for variances and discrepancies

Oversee the active maintenance and improvement of current data warehouses and data pipelines.

Create training documentation and trains junior team members on data pipelining, CI / CD processes, as well as architecture implementation and testing as well as stipulates system troubleshooting support.

Actively communicate with scientists, analytical and process development leads, manufacturing, non-clinical and clinical teams to inform QbD (Quality-by-Design) and systems approaches, data analyses, and engineered improvements driving discovery and development.

Provide and support the implementation of engineering solutions by building relationships and partnerships with key stakeholders, determining and carrying out necessary processes, monitoring progress and results, recognizing and capitalizing on improvement opportunities, adapting to competing demands, organizational changes, and new responsibilities.

Demonstrate up-to-date expertise and apply this to development, execution and improvement of infrastructure setup and provide guidance to others by supporting and aligning efforts by multiple stakeholders.

Work in a matrixed environment by leading projects using a product mindset.

Minimum Requirements / Qualifications :

Master’s degree or higher in a quantitative discipline such as Statistics, Mathematics, Engineering, or Computer Science.

4+ years of experience working in data engineering role in an enterprise environment

Entry-level certification with AWS Cloud or prior experience with developing solutions on cloud computing services and infrastructure in the data and analytics space.

Strong experience developing, working in, and maintaining production data pipelines and production data warehouses

Strong understanding of Software Development Life Cycle (SDLC) as it applies to data systems and project planning / execution skills including estimating and scheduling.

Knowledge of professional software engineering practices & best practices for the full software development life cycle, including coding standards, code reviews, source control management (especially Github), build processes, testing, and operations

Prior experience working in healthcare / pharmaceutical industry.

Ability to read / write Python and R scripts for building data transformation pipelines

Demonstrated experience with a variety of relational database and data warehousing technology such as AWS Redshift, Athena, RDS, BigQuery

Demonstrated experience with big data processing systems and distributed computing technology such as Databricks, Spark, Sagemaker, Kafka, etc.

Solution-oriented enabler mindset and excellent problem-solving skills.

Demonstrated experience working at different levels of leadership in a technical project including individual contributor work.

Prior experience working with non-technical stakeholders to deliver working data content for consumption via adhoc analysis.

Strong interpersonal and communication skills (verbal and written)

Collaborative mindset and teamwork, with the ability to challenge and engage an audience towards better outcomes

Ability and prior experience navigating a challenging, matrixed organization

Ability and willingness to multi-task across a range of functional and technical contexts

Nice-to-have’s :

Prior experience with data analysis including aggregation, cross-data-set analyses, generating confusion matrices, exception finding, and data mapping

Ability to read / write ANSI-compatible SQL from scratch including selects and aggregate functions, DDL / DML

Prior experience in consulting or analytics project delivery through the entire software lifecyle : Requirements, Design, Testing, Deployment

Prior experience developing documentation for a data platform

Prior experience designing and implementing data architectures, including tables, views, facts, dimensions

Prior experience with Data Engineering projects and teams at an Enterprise level

Strong experience with ETL / ELT design and implementations in the context of large, disparate, and complex datasets

Prior experience managing, overseeing, and guiding junior data engineers.

Prior experience working in manufacturing facilities.

What Takeda can offer you :

Comprehensive Healthcare : Medical, Dental, and Vision

Financial Planning & Stability : 401(k) with company match and Annual Retirement Contribution Plan

Health & Wellness programs including onsite flu shots and health screenings

Generous time off for vacation and the option to purchase additional vacation days

Community Outreach Programs and company match of charitable contributions

Family Planning Support

Flexible Work Paths

Tuition reimbursement

More about us :

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.

We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Base Salary Range : $102,200.00 to $146,000.00, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well.

Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

LI-Hybrid

LI-AA1

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use .

I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role :

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.

By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Senior Data Engineer where you will lead the implementation of development, testing, automation tools and IT infrastructure in line with SDLC principles and leading implementation of DevOps through the entire architecture.

You will report to the Head, Digital Platforms and Manufacturing Informatics Cell Therapy and will be a part of the Cell Therapy Engineering and Automation team.

How you will contribute :

Lead the implementation of various development, testing, automation tools and IT infrastructure in line with SDLC principles and leading implementation of DevOps through the entire architecture.

Specifically, lead continuous improvement and build continuous integration, development, and constant deployment pipelines.

Write code to develop and test the required solution and architecture features to enable seamless data pipelining and flow to many different end-applications such as front-end visualization platform, Tableau dashboards etc.

Test the code using the appropriate testing approach. Deploys software to production servers. Contributes code documentation, maintains playbooks, and provides timely progress updates

Define relational tables, primary and foreign keys, and stored procedures to create a data model structure. Evaluates existing data models and physical databases for variances and discrepancies

Oversee the active maintenance and improvement of current data warehouses and data pipelines.

Create training documentation and trains junior team members on data pipelining, CI / CD processes, as well as architecture implementation and testing as well as stipulates system troubleshooting support.

Actively communicate with scientists, analytical and process development leads, manufacturing, non-clinical and clinical teams to inform QbD (Quality-by-Design) and systems approaches, data analyses, and engineered improvements driving discovery and development.

Provide and support the implementation of engineering solutions by building relationships and partnerships with key stakeholders, determining and carrying out necessary processes, monitoring progress and results, recognizing and capitalizing on improvement opportunities, adapting to competing demands, organizational changes, and new responsibilities.

Demonstrate up-to-date expertise and apply this to development, execution and improvement of infrastructure setup and provide guidance to others by supporting and aligning efforts by multiple stakeholders.

Work in a matrixed environment by leading projects using a product mindset.

Minimum Requirements / Qualifications :

Master’s degree or higher in a quantitative discipline such as Statistics, Mathematics, Engineering, or Computer Science.

4+ years of experience working in data engineering role in an enterprise environment

Entry-level certification with AWS Cloud or prior experience with developing solutions on cloud computing services and infrastructure in the data and analytics space.

Strong experience developing, working in, and maintaining production data pipelines and production data warehouses

Strong understanding of Software Development Life Cycle (SDLC) as it applies to data systems and project planning / execution skills including estimating and scheduling.

Knowledge of professional software engineering practices & best practices for the full software development life cycle, including coding standards, code reviews, source control management (especially Github), build processes, testing, and operations

Prior experience working in healthcare / pharmaceutical industry.

Ability to read / write Python and R scripts for building data transformation pipelines

Demonstrated experience with a variety of relational database and data warehousing technology such as AWS Redshift, Athena, RDS, BigQuery

Demonstrated experience with big data processing systems and distributed computing technology such as Databricks, Spark, Sagemaker, Kafka, etc.

Solution-oriented enabler mindset and excellent problem-solving skills.

Demonstrated experience working at different levels of leadership in a technical project including individual contributor work.

Prior experience working with non-technical stakeholders to deliver working data content for consumption via adhoc analysis.

Strong interpersonal and communication skills (verbal and written)

Collaborative mindset and teamwork, with the ability to challenge and engage an audience towards better outcomes

Ability and prior experience navigating a challenging, matrixed organization

Ability and willingness to multi-task across a range of functional and technical contexts

Nice-to-have’s :

Prior experience with data analysis including aggregation, cross-data-set analyses, generating confusion matrices, exception finding, and data mapping

Ability to read / write ANSI-compatible SQL from scratch including selects and aggregate functions, DDL / DML

Prior experience in consulting or analytics project delivery through the entire software lifecyle : Requirements, Design, Testing, Deployment

Prior experience developing documentation for a data platform

Prior experience designing and implementing data architectures, including tables, views, facts, dimensions

Prior experience with Data Engineering projects and teams at an Enterprise level

Strong experience with ETL / ELT design and implementations in the context of large, disparate, and complex datasets

Prior experience managing, overseeing, and guiding junior data engineers.

Prior experience working in manufacturing facilities.

What Takeda can offer you :

Comprehensive Healthcare : Medical, Dental, and Vision

Financial Planning & Stability : 401(k) with company match and Annual Retirement Contribution Plan

Health & Wellness programs including onsite flu shots and health screenings

Generous time off for vacation and the option to purchase additional vacation days

Community Outreach Programs and company match of charitable contributions

Family Planning Support

Flexible Work Paths

Tuition reimbursement

More about us :

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.

We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Base Salary Range : $102,200.00 to $146,000.00, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well.

Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

LI-Hybrid

LI-AA1

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use .

I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role :

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.

By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Senior Data Engineer where you will lead the implementation of development, testing, automation tools and IT infrastructure in line with SDLC principles and leading implementation of DevOps through the entire architecture.

You will report to the Head, Digital Platforms and Manufacturing Informatics Cell Therapy and will be a part of the Cell Therapy Engineering and Automation team.

How you will contribute :

Lead the implementation of various development, testing, automation tools and IT infrastructure in line with SDLC principles and leading implementation of DevOps through the entire architecture.

Specifically, lead continuous improvement and build continuous integration, development, and constant deployment pipelines.

Write code to develop and test the required solution and architecture features to enable seamless data pipelining and flow to many different end-applications such as front-end visualization platform, Tableau dashboards etc.

Test the code using the appropriate testing approach. Deploys software to production servers. Contributes code documentation, maintains playbooks, and provides timely progress updates

Define relational tables, primary and foreign keys, and stored procedures to create a data model structure. Evaluates existing data models and physical databases for variances and discrepancies

Oversee the active maintenance and improvement of current data warehouses and data pipelines.

Create training documentation and trains junior team members on data pipelining, CI / CD processes, as well as architecture implementation and testing as well as stipulates system troubleshooting support.

Actively communicate with scientists, analytical and process development leads, manufacturing, non-clinical and clinical teams to inform QbD (Quality-by-Design) and systems approaches, data analyses, and engineered improvements driving discovery and development.

Provide and support the implementation of engineering solutions by building relationships and partnerships with key stakeholders, determining and carrying out necessary processes, monitoring progress and results, recognizing and capitalizing on improvement opportunities, adapting to competing demands, organizational changes, and new responsibilities.

Demonstrate up-to-date expertise and apply this to development, execution and improvement of infrastructure setup and provide guidance to others by supporting and aligning efforts by multiple stakeholders.

Work in a matrixed environment by leading projects using a product mindset.

Minimum Requirements / Qualifications :

Master’s degree or higher in a quantitative discipline such as Statistics, Mathematics, Engineering, or Computer Science.

4+ years of experience working in data engineering role in an enterprise environment

Entry-level certification with AWS Cloud or prior experience with developing solutions on cloud computing services and infrastructure in the data and analytics space.

Strong experience developing, working in, and maintaining production data pipelines and production data warehouses

Strong understanding of Software Development Life Cycle (SDLC) as it applies to data systems and project planning / execution skills including estimating and scheduling.

Knowledge of professional software engineering practices & best practices for the full software development life cycle, including coding standards, code reviews, source control management (especially Github), build processes, testing, and operations

Prior experience working in healthcare / pharmaceutical industry.

Ability to read / write Python and R scripts for building data transformation pipelines

Demonstrated experience with a variety of relational database and data warehousing technology such as AWS Redshift, Athena, RDS, BigQuery

Demonstrated experience with big data processing systems and distributed computing technology such as Databricks, Spark, Sagemaker, Kafka, etc.

Solution-oriented enabler mindset and excellent problem-solving skills.

Demonstrated experience working at different levels of leadership in a technical project including individual contributor work.

Prior experience working with non-technical stakeholders to deliver working data content for consumption via adhoc analysis.

Strong interpersonal and communication skills (verbal and written)

Collaborative mindset and teamwork, with the ability to challenge and engage an audience towards better outcomes

Ability and prior experience navigating a challenging, matrixed organization

Ability and willingness to multi-task across a range of functional and technical contexts

Nice-to-have’s :

Prior experience with data analysis including aggregation, cross-data-set analyses, generating confusion matrices, exception finding, and data mapping

Ability to read / write ANSI-compatible SQL from scratch including selects and aggregate functions, DDL / DML

Prior experience in consulting or analytics project delivery through the entire software lifecyle : Requirements, Design, Testing, Deployment

Prior experience developing documentation for a data platform

Prior experience designing and implementing data architectures, including tables, views, facts, dimensions

Prior experience with Data Engineering projects and teams at an Enterprise level

Strong experience with ETL / ELT design and implementations in the context of large, disparate, and complex datasets

Prior experience managing, overseeing, and guiding junior data engineers.

Prior experience working in manufacturing facilities.

What Takeda can offer you :

Comprehensive Healthcare : Medical, Dental, and Vision

Financial Planning & Stability : 401(k) with company match and Annual Retirement Contribution Plan

Health & Wellness programs including onsite flu shots and health screenings

Generous time off for vacation and the option to purchase additional vacation days

Community Outreach Programs and company match of charitable contributions

Family Planning Support

Flexible Work Paths

Tuition reimbursement

More about us :

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.

We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Base Salary Range : $102,200.00 to $146,000.00, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well.

Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

LI-Hybrid

LI-AA1

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use .

I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role :

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.

By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Senior Data Engineer where you will lead the implementation of development, testing, automation tools and IT infrastructure in line with SDLC principles and leading implementation of DevOps through the entire architecture.

You will report to the Head, Digital Platforms and Manufacturing Informatics Cell Therapy and will be a part of the Cell Therapy Engineering and Automation team.

How you will contribute :

Lead the implementation of various development, testing, automation tools and IT infrastructure in line with SDLC principles and leading implementation of DevOps through the entire architecture.

Specifically, lead continuous improvement and build continuous integration, development, and constant deployment pipelines.

Write code to develop and test the required solution and architecture features to enable seamless data pipelining and flow to many different end-applications such as front-end visualization platform, Tableau dashboards etc.

Test the code using the appropriate testing approach. Deploys software to production servers. Contributes code documentation, maintains playbooks, and provides timely progress updates

Define relational tables, primary and foreign keys, and stored procedures to create a data model structure. Evaluates existing data models and physical databases for variances and discrepancies

Oversee the active maintenance and improvement of current data warehouses and data pipelines.

Create training documentation and trains junior team members on data pipelining, CI / CD processes, as well as architecture implementation and testing as well as stipulates system troubleshooting support.

Actively communicate with scientists, analytical and process development leads, manufacturing, non-clinical and clinical teams to inform QbD (Quality-by-Design) and systems approaches, data analyses, and engineered improvements driving discovery and development.

Provide and support the implementation of engineering solutions by building relationships and partnerships with key stakeholders, determining and carrying out necessary processes, monitoring progress and results, recognizing and capitalizing on improvement opportunities, adapting to competing demands, organizational changes, and new responsibilities.

Demonstrate up-to-date expertise and apply this to development, execution and improvement of infrastructure setup and provide guidance to others by supporting and aligning efforts by multiple stakeholders.

Work in a matrixed environment by leading projects using a product mindset.

Minimum Requirements / Qualifications :

Master’s degree or higher in a quantitative discipline such as Statistics, Mathematics, Engineering, or Computer Science.

4+ years of experience working in data engineering role in an enterprise environment

Entry-level certification with AWS Cloud or prior experience with developing solutions on cloud computing services and infrastructure in the data and analytics space.

Strong experience developing, working in, and maintaining production data pipelines and production data warehouses

Strong understanding of Software Development Life Cycle (SDLC) as it applies to data systems and project planning / execution skills including estimating and scheduling.

Knowledge of professional software engineering practices & best practices for the full software development life cycle, including coding standards, code reviews, source control management (especially Github), build processes, testing, and operations

Prior experience working in healthcare / pharmaceutical industry.

Ability to read / write Python and R scripts for building data transformation pipelines

Demonstrated experience with a variety of relational database and data warehousing technology such as AWS Redshift, Athena, RDS, BigQuery

Demonstrated experience with big data processing systems and distributed computing technology such as Databricks, Spark, Sagemaker, Kafka, etc.

Solution-oriented enabler mindset and excellent problem-solving skills.

Demonstrated experience working at different levels of leadership in a technical project including individual contributor work.

Prior experience working with non-technical stakeholders to deliver working data content for consumption via adhoc analysis.

Strong interpersonal and communication skills (verbal and written)

Collaborative mindset and teamwork, with the ability to challenge and engage an audience towards better outcomes

Ability and prior experience navigating a challenging, matrixed organization

Ability and willingness to multi-task across a range of functional and technical contexts

Nice-to-have’s :

Prior experience with data analysis including aggregation, cross-data-set analyses, generating confusion matrices, exception finding, and data mapping

Ability to read / write ANSI-compatible SQL from scratch including selects and aggregate functions, DDL / DML

Prior experience in consulting or analytics project delivery through the entire software lifecyle : Requirements, Design, Testing, Deployment

Prior experience developing documentation for a data platform

Prior experience designing and implementing data architectures, including tables, views, facts, dimensions

Prior experience with Data Engineering projects and teams at an Enterprise level

Strong experience with ETL / ELT design and implementations in the context of large, disparate, and complex datasets

Prior experience managing, overseeing, and guiding junior data engineers.

Prior experience working in manufacturing facilities.

What Takeda can offer you :

Comprehensive Healthcare : Medical, Dental, and Vision

Financial Planning & Stability : 401(k) with company match and Annual Retirement Contribution Plan

Health & Wellness programs including onsite flu shots and health screenings

Generous time off for vacation and the option to purchase additional vacation days

Community Outreach Programs and company match of charitable contributions

Family Planning Support

Flexible Work Paths

Tuition reimbursement

More about us :

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.

We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Base Salary Range : $102,200.00 to $146,000.00, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well.

Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

LI-Hybrid

LI-AA1

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use .

I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Takeda Development Center Americas, Inc. is seeking a Manager, Programming in Lexington, MA with the following requirements : Bachelor’s degree in Computer Science or related field or foreign academic equivalent plus 6 years of related experience OR Master’s degree in Computer Science or related field or foreign academic equivalent plus 4 years of related experience.

• Prior experience must include : Lead studies from the initial setup to submission (FDA, PMDA, EU); Drive innovative solutions by leading Python programming team to automate the process of preparing and inserting in-text tables into CSR report and contribute to develop R tool to convert multiple RTF and DOCX files to PDF and create combined PDF file with bookmarks;
• Deliver complex graphical presentations : broken / split Y axis Bar chart, Forest plot, KM plot, Waterfall plot using sgrender, sgplot and proc template;

build up and manage global teams across geographic regions for 4 years. Company headquarters in Lexington, MA. Individual may reside anywhere in the U.

S. Up to 100% telecommuting allowed from any location in the U.S.

Apply on-line at www.takedajobs.com and search for Req # R0093470.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use .

I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role :

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.

By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.

Join Takeda as a Sr Manager., Global Labeling (Remote)

How you will contribute :

Leads cross-functional teams to develop and update CCDS and other key global labeling documents ( i.e. CCDS Working Team).

In coordination with Global Labeling Oversight Committee (GLOC) Chair, manages review and approval of CCDS / resolution of labeling issues with the relevant GLOC.

Authors / manages outgoing communications regarding significant labeling changes and CCDS changes for assigned products.

Evaluates risks associated with CCDS content and implementation strategies, develop mitigation plans, and appropriately escalate issues to Global Labeling management and the Global Regulatory Lead.

Recommends strategies and labeling language for inclusion in key product labels (US PI, EU SmPC, JPI, others as appropriate), consistent with the overall product strategy and information in the CCDS, when available.

Provides labeling strategy and guidance to Local Operating Company (LOC) Regulatory, in collaboration with the RA Sub team.

Provides information to Global Labeling Compliance, as required, to support internal and external ( i.e. Regulatory Authority) requirements and support audits / inspections as a labeling subject matter expert.

Liaises with US Labeling Operations and EU Labeling Operations to ensure labeling objectives and timelines are met.

Remains current with global standards and, initiatives by regulatory authorities related to the CCDS and labeling, and assures that Takeda processes conform to regulatory requirements.

Propose actions as needed.

Identifies and leads initiatives, as requested, to enhance Global Labeling processes and systems. Participates in training LOC regulations on relevant labeling policies and procedures, as needed.

Prepares training materials as required.

Minimum Requirements / Qualifications :

BSc Degree is preferred. BA accepted.

Senior Manager : 6+ years of pharmaceutical industry experience. This is inclusive of 5 years of labeling experience a combination of 6+ years of regulatory and / or related experience.

Understanding of scientific principles and regulatory / quality systems relevant to drug development.

Knowledge of global standards and regulations related to CCDS and Product Labeling (US PI and EU SmPC experience required, other regional labels also preferred).

Strong oral and written communication, managing and adhering to timelines, negotiation skills, integrity, and adaptability.

Demonstrates problem-solving ability with the ability to analyze risk and make appropriate recommendations / decisions.

Must work well with others and within global teams.

Acceptable and independent skills in regulatory affairs such as understanding broad concepts within labeling and implications across the organization and globally;

proactively identifying issues; offering creative solutions and strategies, including risk mitigation strategies.

What Takeda can offer you :

Comprehensive Healthcare : Medical, Dental, and Vision

Financial Planning & Stability : 401(k) with company match and Annual Retirement Contribution Plan

Health & Wellness programs including onsite flu shots and health screenings

Generous time off for vacation and the option to purchase additional vacation days

Community Outreach Programs and a company match of charitable contributions

Family Planning Support

Flexible Work Paths

Tuition reimbursement

More about us :

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs.

Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.

We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.

Base Salary Range : $124,600 to $178,000, based on the candidate's professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well.

Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

LI-Remote

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use .

I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role :

The Senior / Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global regulatory strategies and providing strategic regulatory guidance for the global development of various products within the Neuroscience Therapeutic Area Unit (TAU) portfolio.

This is accomplished through leadership of product-specific Global Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams.

The Senior / Director also will lead discussions of regulatory strategy with senior leadership of the TAU and where appropriate R&D.

OBJECTIVES :

• Defines, develops, and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and / or multiple projects.
• Keeps abreast of new developments in regulatory science and maintains oversight on the evolving regulatory landscape and advancing innovations.
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.
• Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable.

Represents Takeda as applicable in industry / regulatory forums to lead regulatory innovation.

Join Takeda as a Senior Director / Director Global Regulatory Affairs Global Regulatory Lead Neuroscience, based in Cambridge, MA.

How you will contribute :

ACCOUNTABILITIES

• Will be responsible for complex and potentially multiple projects within a Neuroscience TAU Franchise. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups and represents GRTs at project team meetings.
• Collaborate across technical functions to create innovative regulatory strategies for projects and pragmatic solutions to deliver on the proposed strategy with the project teams. .
• Will work closely with and report to a Neuroscience TAU Franchise Regulatory Lead and may provide oversight of direct reports or junior staff.
• Effectively communicates through presentations and written communications regulatory strategies and project developments to project teams, colleagues, line management, and key stakeholders for alignment and to ensure awareness of issues that may impact regulatory success.

Communications demonstrate sound judgement and are provided in a professional and timely manner.

Responsible for proactively anticipating regulatory risks and for developing mitigation strategies in alignment with team and management;

understands relative strengths, weakness, and probabilities of technical success for the mitigation strategies proposed.

• The Sr Director / Director will be accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible.
• Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed.
• Leads the GRT and proactively solicits input from regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and support the project objectives.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• Participates with influence in or leads departmental and cross-functional taskforces and initiatives.
• Serves as lead regulatory reviewer in due diligence for licensing opportunities.
• Partner with global market access colleagues to lead interactions with joint regulatory / health agency / HTA bodies on product specific value evidence topics, as applicable.
• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
• Responsible for demonstrating Takeda leadership behaviors

Minimum Requirements / Qualifications :

• Advanced degree in a scientific subject area (e.g. MSc, PhD, PharmD, MD). BA acceptable with significant Industry experience.
• Sr Director 12+ years of pharmaceutical industry experience inclusive of 10 years of regulatory experience or a combination of 8+ years of regulatory and related experience.

Director 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or a combination of 5+ years regulatory and / or related experience.

Experience in Neuroscience preferred.

• Expectations will include :
• Understands and works effectively with a Global Regulatory Team to develop the regulatory framework for the clinical development of small molecules and biologic products leading to global marketing authorizations.
• Ability to advise on applicable regulations and guidance documents, including providing interpretation of these governing documents by regulators as experience is gained in practice.
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.
• Keeps abreast of new developments and therapeutic innovations, including regulatory requirements related to gene therapy and associated science.
• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability.
• Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally;

proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.

Demonstrated ability to work well within global teams and success leading cross-functional regulatory work products.

What Takeda can offer you :

• Comprehensive Healthcare : Medical, Dental, and Vision
• Financial Planning & Stability : 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Flexible Work Paths
• Tuition reimbursement

More about us :

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.

We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

LOCATION :

Cambridge, MA or Hybrid

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use .

I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.

By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Director Global Regulatory Affairs CMC - Biologics where you will oversee the development and execution of regulatory CMC development and registration strategies.

You may manage staff members. As part of the Global Regulatory Affairs CMC team, you will report to the Executive or Senior Director and work with Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff.

How you will contribute :

Demonstrate Takeda leadership behaviors.

Independently manage regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities.

Participate in global teams that require experienced interpretation of applicable EMA / FDA / ICH / WHO / Global regulations to ensure CMC compliance.

Evaluate change proposals for regulatory impact and filing requirements.

Lead team members that establish CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements.

Lead and contribute to business process development.

Evaluate new business development opportunities or represent Global Regulatory Affairs CMC on due diligence teams.

Maintain constructive relations with essential colleagues, e.g. colleagues within Takeda, Alliance Partners, and Health Authority representatives.

Ensure that project team colleagues, line management, and partners are informed of developments that may affect regulatory success.

Elevate and communicate actual or potential issues to line management.

Successfully communicate and negotiate with international Health Authorities, directly and indirectly.

Represent Takeda Global Regulatory Affairs CMC in Health Authority meetings and lead CMC preparation activities for meetings with Health Authorities on CMC-related matters.

Manage and support staff, if required, including staff professional development and project oversight.

Minimum Requirements / Qualifications :

BS / BA Degree in a Scientific Discipline, Advanced Degree preferred.

10+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience, with international experience strongly preferred.

Experience liaising with Regulatory Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred.

Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.

Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams.

Ability to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear / specific regulatory guidance.

Demonstrated leadership, problem-solving ability, flexibility and teamwork.

Good judgement in elevating and communicating actual or potential issues to line management.

Excellent written and oral communication skills.

Experience of active participation in Agency / Industry groups / forums expected.

What Takeda can offer you :

Comprehensive Healthcare : Medical, Dental, and Vision

Financial Planning & Stability : 401(k) with company match and Annual Retirement Contribution Plan

Health & Wellness programs including onsite flu shots and health screenings

Generous time off for vacation and the option to purchase additional vacation days

Community Outreach Programs and company match of charitable contributions

Family Planning Support

Flexible Work Paths

Tuition reimbursement

More about us :

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.

We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Travel Requirements :

Willingness to travel to various meetings, including overnight trips.

Requires approximately up to 10-30% travel.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Location and Salary Information :

Base Salary Range : $156,800- $224,000 based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well.

Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply

Empowering our people to shine :

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Lexington, MA

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use .

I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role :

The Senior / Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global regulatory strategies and providing strategic regulatory guidance for the global development of various products within the Neuroscience Therapeutic Area Unit (TAU) portfolio.

This is accomplished through leadership of product-specific Global Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams.

The Senior / Director also will lead discussions of regulatory strategy with senior leadership of the TAU and where appropriate R&D.

OBJECTIVES :

• Defines, develops, and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and / or multiple projects.
• Keeps abreast of new developments in regulatory science and maintains oversight on the evolving regulatory landscape and advancing innovations.
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.
• Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable.

Represents Takeda as applicable in industry / regulatory forums to lead regulatory innovation.

Join Takeda as a Senior Director / Director Global Regulatory Affairs Global Regulatory Lead Neuroscience, based in Cambridge, MA.

How you will contribute :

ACCOUNTABILITIES

• Will be responsible for complex and potentially multiple projects within a Neuroscience TAU Franchise. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups and represents GRTs at project team meetings.
• Collaborate across technical functions to create innovative regulatory strategies for projects and pragmatic solutions to deliver on the proposed strategy with the project teams. .
• Will work closely with and report to a Neuroscience TAU Franchise Regulatory Lead and may provide oversight of direct reports or junior staff.
• Effectively communicates through presentations and written communications regulatory strategies and project developments to project teams, colleagues, line management, and key stakeholders for alignment and to ensure awareness of issues that may impact regulatory success.

Communications demonstrate sound judgement and are provided in a professional and timely manner.

Responsible for proactively anticipating regulatory risks and for developing mitigation strategies in alignment with team and management;

understands relative strengths, weakness, and probabilities of technical success for the mitigation strategies proposed.

• The Sr Director / Director will be accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible.
• Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed.
• Leads the GRT and proactively solicits input from regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and support the project objectives.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• Participates with influence in or leads departmental and cross-functional taskforces and initiatives.
• Serves as lead regulatory reviewer in due diligence for licensing opportunities.
• Partner with global market access colleagues to lead interactions with joint regulatory / health agency / HTA bodies on product specific value evidence topics, as applicable.
• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
• Responsible for demonstrating Takeda leadership behaviors

Minimum Requirements / Qualifications :

• Advanced degree in a scientific subject area (e.g. MSc, PhD, PharmD, MD). BA acceptable with significant Industry experience.
• Sr Director 12+ years of pharmaceutical industry experience inclusive of 10 years of regulatory experience or a combination of 8+ years of regulatory and related experience.

Director 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or a combination of 5+ years regulatory and / or related experience.

Experience in Neuroscience preferred.

• Expectations will include :
• Understands and works effectively with a Global Regulatory Team to develop the regulatory framework for the clinical development of small molecules and biologic products leading to global marketing authorizations.
• Ability to advise on applicable regulations and guidance documents, including providing interpretation of these governing documents by regulators as experience is gained in practice.
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.
• Keeps abreast of new developments and therapeutic innovations, including regulatory requirements related to gene therapy and associated science.
• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability.
• Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally;

proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.

Demonstrated ability to work well within global teams and success leading cross-functional regulatory work products.

What Takeda can offer you :

• Comprehensive Healthcare : Medical, Dental, and Vision
• Financial Planning & Stability : 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Flexible Work Paths
• Tuition reimbursement

More about us :

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.

We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

LOCATION :

Cambridge, MA or Hybrid

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use .

I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role :

The Senior / Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global regulatory strategies and providing strategic regulatory guidance for the global development of various products within the Neuroscience Therapeutic Area Unit (TAU) portfolio.

This is accomplished through leadership of product-specific Global Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams.

The Senior / Director also will lead discussions of regulatory strategy with senior leadership of the TAU and where appropriate R&D.

OBJECTIVES :

• Defines, develops, and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and / or multiple projects.
• Keeps abreast of new developments in regulatory science and maintains oversight on the evolving regulatory landscape and advancing innovations.
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.
• Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable.

Represents Takeda as applicable in industry / regulatory forums to lead regulatory innovation.

Join Takeda as a Senior Director / Director Global Regulatory Affairs Global Regulatory Lead Neuroscience, based in Cambridge, MA.

How you will contribute :

ACCOUNTABILITIES

• Will be responsible for complex and potentially multiple projects within a Neuroscience TAU Franchise. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups and represents GRTs at project team meetings.
• Collaborate across technical functions to create innovative regulatory strategies for projects and pragmatic solutions to deliver on the proposed strategy with the project teams. .
• Will work closely with and report to a Neuroscience TAU Franchise Regulatory Lead and may provide oversight of direct reports or junior staff.
• Effectively communicates through presentations and written communications regulatory strategies and project developments to project teams, colleagues, line management, and key stakeholders for alignment and to ensure awareness of issues that may impact regulatory success.

Communications demonstrate sound judgement and are provided in a professional and timely manner.

Responsible for proactively anticipating regulatory risks and for developing mitigation strategies in alignment with team and management;

understands relative strengths, weakness, and probabilities of technical success for the mitigation strategies proposed.

• The Sr Director / Director will be accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible.
• Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed.
• Leads the GRT and proactively solicits input from regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and support the project objectives.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• Participates with influence in or leads departmental and cross-functional taskforces and initiatives.
• Serves as lead regulatory reviewer in due diligence for licensing opportunities.
• Partner with global market access colleagues to lead interactions with joint regulatory / health agency / HTA bodies on product specific value evidence topics, as applicable.
• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
• Responsible for demonstrating Takeda leadership behaviors

Minimum Requirements / Qualifications :

• Advanced degree in a scientific subject area (e.g. MSc, PhD, PharmD, MD). BA acceptable with significant Industry experience.
• Sr Director 12+ years of pharmaceutical industry experience inclusive of 10 years of regulatory experience or a combination of 8+ years of regulatory and related experience.

Director 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or a combination of 5+ years regulatory and / or related experience.

Experience in Neuroscience preferred.

• Expectations will include :
• Understands and works effectively with a Global Regulatory Team to develop the regulatory framework for the clinical development of small molecules and biologic products leading to global marketing authorizations.
• Ability to advise on applicable regulations and guidance documents, including providing interpretation of these governing documents by regulators as experience is gained in practice.
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.
• Keeps abreast of new developments and therapeutic innovations, including regulatory requirements related to gene therapy and associated science.
• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability.
• Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally;

proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.

Demonstrated ability to work well within global teams and success leading cross-functional regulatory work products.

What Takeda can offer you :

• Comprehensive Healthcare : Medical, Dental, and Vision
• Financial Planning & Stability : 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Flexible Work Paths
• Tuition reimbursement

More about us :

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.

We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

LOCATION :

Cambridge, MA or Hybrid

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use .

I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role :

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.

By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.

Join Takeda as a Senior Manager, at Global Regulatory Affairs CMC where you will develop and lead the execution of regulatory CMC investigational, registration, and post-approval strategies for assigned products.

You will also with moderate guidance, communicate and negotiate with international Health Authorities, directly and indirectly.

As part of the Global Regulatory Affairs CMC team, you will work with Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.

How you will contribute :

Plan and execute regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities.

As a GRA CMC product leader or team member, ensures and enhances regulatory compliance for filing requirements for assigned compounds throughout development and the commercial life cycle.

Independently define CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with the established requirement.

With moderate guidance, represents Takeda RA CMC in Health Authority meetings and leads CMC preparation activities for meetings with Health Authorities on CMC-related matters.

Interact directly with international Health Authorities.

Ensure project team colleagues, line management, and partners are informed of developments that may affect regulatory success.

Foster constructive working relationships when working with all colleagues.

Evaluate change proposals for global regulatory impact. and plans global variations and amendments.

Minimum Requirements / Qualifications :

BS / BA Degree in a Scientific Discipline, Advanced Degree preferred.

6+ years of pharmaceutical Regulatory CMC experience, including experience as an RA CMC product lead, or equivalent industry experience.

e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance).

Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.

Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams.

Able to deal with issues of essential importance. Provide regulatory advice and make reasoned decisions on regulatory issues for which there may not be clear / specific regulatory guidance.

Demonstrate new leadership, problem-solving ability, attention to detail, flexibility, and values teamwork.

Exercise good judgment in elevating and communicating actual or potential issues to line management.

Excellent written and oral communication skills.

Active participation in Agency / Industry groups / forums is preferred.

What Takeda can offer you :

Comprehensive Healthcare : Medical, Dental, and Vision

Financial Planning & Stability : 401(k) with company match and Annual Retirement Contribution Plan

Health & Wellness programs including onsite flu shots and health screenings

Generous time off for vacation and the option to purchase additional vacation days

Community Outreach Programs and a company match of charitable contributions

Family Planning Support

Flexible Work Paths

Tuition reimbursement

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Location and Salary Information :

Base Salary Range : $124,600 to $178,000 based on the candidate's professional experience level. Employees may also be eligible for Short-Term and Long-Term Incentive benefits as well.

Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

More about us :

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs.

Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.

We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine :

Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time