Takeda
Director, Global Regulatory Affairs CMC
Takeda, Lexington, Massachusetts, United States, 02173
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Takeda’s
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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 Director GRA CMC where you will independently develop and lead the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products as GRA CMC Product Lead. You will represent and contribute to Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle. Demonstrating a high level of leadership and expert understanding of GRA CMC regulations and guidelines, you will apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. A strong analytical or process understanding will enable the development of robust and accurate submissions.You will also develop constructive relationships and proactively communicate issues to key internal and external colleagues, including Alliance Partners. Successfully communicate and negotiate with Health Authorities directly and indirectly. Apply expert GRA CMC knowledge to address and overcome challenges that arise during development and commercialization. Coach and develop people and teams, recruit and reward to retain talent. Support a culture of high performance and trust, assure that the required level of knowledge and skills is available and identify competency gaps. Establish and implement effective development plans.As part of the GRA CMC team, you will report to the Senior Director GRA CMC and work cross-functionally across the business.How you will contribute:
Develop, execute and oversee regulatory submissions preparation per the GRA CMC Product Team CMC strategy.Guide the team to define and drive strategy for CMC regulatory dossier content and review this content for conformance with established requirements.Represent Takeda GRA CMC in Health Authority meetings and drive preparation activities for meetings with Health Authorities on CMC related matters.Provide guidance to the teams on administrative procedural topics while interacting with International Health Authorities as required.Foster constructive working relationships when interacting with internal and/or external colleagues.Provide strategic input into change control evaluation as required.Ensure and/or enhance regulatory compliance.Keep project team colleagues, line management, and key stakeholders apprised of developments that may impact regulatory success.Contribute to the strategy of the modality functional team and GRA-CMC if a member of the modality management team.Lead a group of regulatory individuals to ensure timely delivery of high-quality regulatory dossiers and strategies according to agreed business priorities.Provide project and administrative oversight to support team’s goals according to agreed timelines, mentor and guide direct reports, develop talent, foster DEI principles and ensure open communication.Review, provide regulatory CMC input and approve technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards.Prepare and maintain relevant regulatory documentation and provide tactical regulatory guidance to product teams in line with global regulatory strategies.Proactively identify regulatory CMC risks and ensure timely communication with line management.Lead assigned global regulatory submissions through product lifecycle.Provide global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations.Work effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions to ensure effective strategies are implemented and project execution is on target.Support development of strategies, tools, and trainings to further the GRA CMC roadmap.Proactively communicate CMC regulatory strategies, key issues and risks through assigned programs/products development activities and LCM in an adequate and timely manner to cross-functional programs/products teams and management level within GRA CMC, GRA, PS, GMS and QA as appropriate.Minimum Requirements/Qualifications:
BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) required.10+ years of overall biopharmaceutical/device industry experience with 8+ years pharmaceutical Regulatory CMC and/or devices experience, while leading major submissions during LCM, development – including preparation of NDA/NLA/MAA.Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines.Able to deal with issues of critical importance with minimal oversight.Exercises good judgment in elevating and communicating actual or potential issues to line management.Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork.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.Locations
Lexington, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeJob ExemptYes
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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 Director GRA CMC where you will independently develop and lead the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products as GRA CMC Product Lead. You will represent and contribute to Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle. Demonstrating a high level of leadership and expert understanding of GRA CMC regulations and guidelines, you will apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. A strong analytical or process understanding will enable the development of robust and accurate submissions.You will also develop constructive relationships and proactively communicate issues to key internal and external colleagues, including Alliance Partners. Successfully communicate and negotiate with Health Authorities directly and indirectly. Apply expert GRA CMC knowledge to address and overcome challenges that arise during development and commercialization. Coach and develop people and teams, recruit and reward to retain talent. Support a culture of high performance and trust, assure that the required level of knowledge and skills is available and identify competency gaps. Establish and implement effective development plans.As part of the GRA CMC team, you will report to the Senior Director GRA CMC and work cross-functionally across the business.How you will contribute:
Develop, execute and oversee regulatory submissions preparation per the GRA CMC Product Team CMC strategy.Guide the team to define and drive strategy for CMC regulatory dossier content and review this content for conformance with established requirements.Represent Takeda GRA CMC in Health Authority meetings and drive preparation activities for meetings with Health Authorities on CMC related matters.Provide guidance to the teams on administrative procedural topics while interacting with International Health Authorities as required.Foster constructive working relationships when interacting with internal and/or external colleagues.Provide strategic input into change control evaluation as required.Ensure and/or enhance regulatory compliance.Keep project team colleagues, line management, and key stakeholders apprised of developments that may impact regulatory success.Contribute to the strategy of the modality functional team and GRA-CMC if a member of the modality management team.Lead a group of regulatory individuals to ensure timely delivery of high-quality regulatory dossiers and strategies according to agreed business priorities.Provide project and administrative oversight to support team’s goals according to agreed timelines, mentor and guide direct reports, develop talent, foster DEI principles and ensure open communication.Review, provide regulatory CMC input and approve technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards.Prepare and maintain relevant regulatory documentation and provide tactical regulatory guidance to product teams in line with global regulatory strategies.Proactively identify regulatory CMC risks and ensure timely communication with line management.Lead assigned global regulatory submissions through product lifecycle.Provide global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations.Work effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions to ensure effective strategies are implemented and project execution is on target.Support development of strategies, tools, and trainings to further the GRA CMC roadmap.Proactively communicate CMC regulatory strategies, key issues and risks through assigned programs/products development activities and LCM in an adequate and timely manner to cross-functional programs/products teams and management level within GRA CMC, GRA, PS, GMS and QA as appropriate.Minimum Requirements/Qualifications:
BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) required.10+ years of overall biopharmaceutical/device industry experience with 8+ years pharmaceutical Regulatory CMC and/or devices experience, while leading major submissions during LCM, development – including preparation of NDA/NLA/MAA.Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines.Able to deal with issues of critical importance with minimal oversight.Exercises good judgment in elevating and communicating actual or potential issues to line management.Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork.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.Locations
Lexington, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeJob ExemptYes
#J-18808-Ljbffr