Director, Global Regulatory Affairs CMC
Takeda
August 10, 2026
Remote friendly (Boston, MA)
United States
$177,000 - $278,080 USD yearly
Corporate Functions
Responsibilities:
- Independently develop and lead execution of regulatory CMC investigational, registration, and post-approval strategies; may serve as GRA CMC Product Lead.
- Represent Regulatory, Pharmaceutical Development, and Commercial teams across clinical and commercial lifecycle.
- Lead/execute major global registrational submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations) through product lifecycle.
- Define and drive CMC regulatory dossier content strategy; review for conformance; anticipate future challenges.
- Represent Takeda in Health Authority meetings; prepare CMC-related meeting activities; communicate/negotiates directly and indirectly.
- Provide regulatory CMC input and approvals (e.g., protocols, reports); guide teams on administrative/procedural topics with International Health Authorities.
- Identify regulatory CMC risks; communicate professionally and timely; enhance regulatory compliance.
- Support change controls, deviations, investigations; provide tactical guidance and maintain regulatory documentation (e.g., strategy documents, storyboards, risk assessments).
- Mentoring/ coaching; foster relationships in a matrix environment.
Minimum Requirements/Qualifications:
- BS/BA in a scientific discipline; advanced degree (M.S./Ph.D.) required.
- 10+ years biopharmaceutical/device industry experience; 8+ years Regulatory CMC and/or devices; leading major submissions during LCM/development including NDA/BLA/MAA.
- Strong understanding of scientific principles and global regulatory CMC requirements; ability to communicate regulatory strategy.
- Excellent written/oral communication; strong analytical/process understanding; attention to detail; sound judgment; emerging leadership.
Benefits (as stated):
- Eligible for medical/dental/vision, 401(k) with match, short/long-term disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.
Location: Boston, MA. Hybrid/remote per policy.
- Independently develop and lead execution of regulatory CMC investigational, registration, and post-approval strategies; may serve as GRA CMC Product Lead.
- Represent Regulatory, Pharmaceutical Development, and Commercial teams across clinical and commercial lifecycle.
- Lead/execute major global registrational submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations) through product lifecycle.
- Define and drive CMC regulatory dossier content strategy; review for conformance; anticipate future challenges.
- Represent Takeda in Health Authority meetings; prepare CMC-related meeting activities; communicate/negotiates directly and indirectly.
- Provide regulatory CMC input and approvals (e.g., protocols, reports); guide teams on administrative/procedural topics with International Health Authorities.
- Identify regulatory CMC risks; communicate professionally and timely; enhance regulatory compliance.
- Support change controls, deviations, investigations; provide tactical guidance and maintain regulatory documentation (e.g., strategy documents, storyboards, risk assessments).
- Mentoring/ coaching; foster relationships in a matrix environment.
Minimum Requirements/Qualifications:
- BS/BA in a scientific discipline; advanced degree (M.S./Ph.D.) required.
- 10+ years biopharmaceutical/device industry experience; 8+ years Regulatory CMC and/or devices; leading major submissions during LCM/development including NDA/BLA/MAA.
- Strong understanding of scientific principles and global regulatory CMC requirements; ability to communicate regulatory strategy.
- Excellent written/oral communication; strong analytical/process understanding; attention to detail; sound judgment; emerging leadership.
Benefits (as stated):
- Eligible for medical/dental/vision, 401(k) with match, short/long-term disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.
Location: Boston, MA. Hybrid/remote per policy.