Director, Global Regulatory Affairs CMC
Takeda
June 28, 2026
Remote friendly (Boston, MA)
United States
$177,000 - $278,080 USD yearly
Corporate Functions
Responsibilities:
- Independently develop regulatory CMC strategy and lead execution of investigational, registration, and post-approval regulatory CMC strategies for assigned product(s); serve as GRA CMC Product Lead as needed.
- Represent and contribute to cross-functional teams (Regulatory, Pharmaceutical Development, Commercial) across clinical development and lifecycle.
- Lead preparation and oversight of major global registrational submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations) and ensure dossier content meets requirements.
- Represent Takeda in Health Authority meetings; prepare for CMC-related engagements and communicate/ negotiate with authorities.
- Review/approve technical protocols and reports; provide regulatory CMC input to change controls, deviations, and investigations.
- Proactively identify and communicate regulatory CMC risks; mentor/coach other CMC members; work effectively in a matrix environment.
Minimum Requirements/Qualifications:
- BS/BA in a scientific discipline; MS/PhD required.
- 10+ years biopharmaceutical/device industry experience, including 8+ years Regulatory CMC and/or devices experience; leading major submissions during LCM/development (including NDA/BLA/MAA).
- Strong understanding of scientific principles and global regulatory CMC requirements for development and post-market support.
- Proven ability to analyze issues, assess alternatives, and develop strategy using precedents/regulatory intelligence.
- Excellent written and oral communication; ability to elevate critical issues with minimal oversight.
Benefits (if eligible):
- Medical/dental/vision, 401(k) with match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, up to 80 hours sick time, and up to 120 hours paid vacation (new hires).
- Independently develop regulatory CMC strategy and lead execution of investigational, registration, and post-approval regulatory CMC strategies for assigned product(s); serve as GRA CMC Product Lead as needed.
- Represent and contribute to cross-functional teams (Regulatory, Pharmaceutical Development, Commercial) across clinical development and lifecycle.
- Lead preparation and oversight of major global registrational submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations) and ensure dossier content meets requirements.
- Represent Takeda in Health Authority meetings; prepare for CMC-related engagements and communicate/ negotiate with authorities.
- Review/approve technical protocols and reports; provide regulatory CMC input to change controls, deviations, and investigations.
- Proactively identify and communicate regulatory CMC risks; mentor/coach other CMC members; work effectively in a matrix environment.
Minimum Requirements/Qualifications:
- BS/BA in a scientific discipline; MS/PhD required.
- 10+ years biopharmaceutical/device industry experience, including 8+ years Regulatory CMC and/or devices experience; leading major submissions during LCM/development (including NDA/BLA/MAA).
- Strong understanding of scientific principles and global regulatory CMC requirements for development and post-market support.
- Proven ability to analyze issues, assess alternatives, and develop strategy using precedents/regulatory intelligence.
- Excellent written and oral communication; ability to elevate critical issues with minimal oversight.
Benefits (if eligible):
- Medical/dental/vision, 401(k) with match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, up to 80 hours sick time, and up to 120 hours paid vacation (new hires).