Director - CMC Global Regulatory Affairs - Biologics
1 month ago
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 pos-approval strategies for assigned products as GRA CMC Product Lead. Represents and contributes 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. Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust and accurate submissions.
You will also develop constructive relationships with and proactively communicates 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, recruits and rewards to retain talent. Supports culture of high performance and trust, assures that the required level of knowledge and skills is available and identifies competency gaps. Establishes and implements 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:
- Develops, executes and oversees regulatory submissions preparation per the GRA CMC Product Team CMC strategy. With minimal supervision, develops, plans, executes and manages regulatory submissions per the GRA CMC Product Team technical regulatory strategy
- Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement. Ability to understand the overall product strategy and anticipate future challenges
- Represents Takeda GRA CMC in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC related matters.
- Provide guidance to the teams on administrative procedural topics while interacting with International Heath Authorities - as required.
- Fosters constructive working relationships when interacting with internal and/or external colleagues.
- Providing strategic input into change control evaluation - as required.
- As a GRA CMC member, ensures and / or enhances regulatory compliance.
- Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
- If a member of the modality management team, contributes to the strategy of the modality functional team and GRA-CMC
- Leads a group of regulatory individuals to ensure timely delivery of high quality of regulatory dossiers and strategies according to agreed business priorities.
- As a line manager role, provides project and administrative oversight to support team’s goals according to agreed timelines, provides mentorship and guidance to direct reports, develops talent, fosters DEI principles and ensures open communication.
- Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards.
- When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities.
- Proactively identifies regulatory CMC risks, ensuring timely communication with line management.
- Leads assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle.
- Provides global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations.
- Works effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (e.g., Growth & Emerging Markets, Strategy, Labelling, etc.) to ensure effective strategies are implemented and project execution is on target.
- Supports development of strategies, tools, and trainings to further the GRA CMC roadmap.
- Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in 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 o NDA/NLA/MAA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered. People leadership experience (3+ years) required.
- 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.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
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Cambridge, Massachusetts, United States Takeda Full timeAbout the RoleWe are seeking an experienced Global Regulatory Affairs Director to join our team in Cambridge, MA. In this role, you will play a key part in developing and executing regulatory strategies for biologics development.Job DescriptionAs a Global Regulatory Affairs Director, you will be responsible for leading the execution of regulatory CMC...
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