Associate Director, Global Regulatory Affairs CMC

Job Description

At Takeda, the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization requires a dedicated professional to contribute to the delivery of critical functions for assigned products, including regulatory CMC investigational, registration and/or post‑approval strategies.

This role will contribute to the team’s delivery of critical functions as follows:

• With minimal supervision, develop and lead the execution of regulatory CMC investigational, registration and/or post‑approval strategies for assigned products. Serve as a RA CMC member on the Global Regulatory CMC team and may act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.

• Have a strong and deep foundational understanding of global RA CMC regulations and guidelines, applying and adapting this knowledge to projects to enhance regulatory success and compliance. Demonstrate strong analytical or process understanding that enables the development of robust and accurate submissions.

• 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.

• Able to apply GRA CMC knowledge to address and overcome challenges that arise during development and commercialization.

• With minimal supervision, develop, plan, execute and manage regulatory submissions per the GRA CMC Product Team technical regulatory strategy.

• Independently define CMC content (data and documentation) requirements for regulatory submissions and review this content for conformance with established requirements.

• With supervision, may represent Takeda RA CMC in Health Authority meetings and support CMC preparation activities for meetings with Health Authorities on CMC related matters.

• Interact directly with international Health Authorities on administrative procedural topics, as required.

• Foster constructive working relationships when interacting with internal and/or external colleagues.

• Evaluate change proposals for global regulatory impact.

• As a GRA CMC member, ensure regulatory compliance with HA regulations and assure conformance with Takeda controlled procedures and GRA CMC best practices.

• Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment and communicating in a professional and timely manner.

• Review, provide regulatory CMC input and approve – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards.

• When in a GRA CMC Product Team lead role, prepare and maintain relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provide tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and/or commercial product approvals and meeting targets for projects/products within respective modalities.

• Support and/or lead assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle.

• Work effectively across a complex matrix environment with stakeholders to ensure effective strategies are implemented and project execution is on target.

• 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 program / product teams and management level within GRA CMC, GRA, PS, GMS and QA – as appropriate.

• BS/BA Degree in a Scientific Discipline; an advanced degree (M.S., Ph.D., etc.) preferred.

• 10+ years of overall biopharmaceutical/device industry experience with 5+ years in pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or…