Director, Global Regulatory Affairs CMC
Takeda
August 29, 2026
Remote friendly (Boston, MA)
United States
$177,000 - $278,080 USD yearly
Corporate Functions
Responsibilities:
- Serve as GRA CMC Franchise Lead for TAK-079.
- Independently develop regulatory CMC strategy and lead investigational, registration, and post-approval CMC execution as GRA CMC Product Lead.
- Represent Regulatory/Pharmaceutical Development/Commercial teams across clinical development and lifecycle.
- Apply expert GRA CMC knowledge to ensure regulatory success/compliance; use precedents and regulatory intelligence.
- Build relationships and proactively communicate issues with internal/external teams and Alliance Partners.
- Communicate/negotiates with Health Authorities (direct/indirect).
- Coach/develop teams; identify competency gaps and implement development plans.
- Develop/execute/oversee major global registrational submissions; guide CMC dossier strategy and review content for requirement conformance.
- Represent Takeda GRA CMC in Health Authority meetings; prepare for CMC-related meeting activities.
- Provide regulatory CMC input to change control evaluation; ensure compliance (including change controls, deviations, investigations).
- Review/approve technical protocols/reports and prepare/maintain regulatory documentation (e.g., strategies, storyboards, risk assessments).
- Lead global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations) through product lifecycle.
Qualifications:
- BS/BA in scientific discipline; advanced degree (M.S., Ph.D., etc.) required.
- 10+ years biopharmaceutical/device industry experience with 8+ years Regulatory CMC and/or devices experience, leading major submissions (including NDA/BLA/MAA).
- Strong understanding of scientific principles and global regulatory CMC requirements; proven ability to communicate regulatory strategy.
- High attention to detail, ability to assess alternative approaches, and strong written/oral communication.
- Ability to handle critical issues with minimal oversight; good judgment elevating issues to line management.
Benefits (if applicable to location/employment):
- Medical/dental/vision, 401(k) + match, disability and life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, sick time, and paid vacation.
Application instruction:
- By clicking “Apply,” your employment application process begins and your information will be processed per Takeda’s Privacy Notice and Terms of Use.
- Serve as GRA CMC Franchise Lead for TAK-079.
- Independently develop regulatory CMC strategy and lead investigational, registration, and post-approval CMC execution as GRA CMC Product Lead.
- Represent Regulatory/Pharmaceutical Development/Commercial teams across clinical development and lifecycle.
- Apply expert GRA CMC knowledge to ensure regulatory success/compliance; use precedents and regulatory intelligence.
- Build relationships and proactively communicate issues with internal/external teams and Alliance Partners.
- Communicate/negotiates with Health Authorities (direct/indirect).
- Coach/develop teams; identify competency gaps and implement development plans.
- Develop/execute/oversee major global registrational submissions; guide CMC dossier strategy and review content for requirement conformance.
- Represent Takeda GRA CMC in Health Authority meetings; prepare for CMC-related meeting activities.
- Provide regulatory CMC input to change control evaluation; ensure compliance (including change controls, deviations, investigations).
- Review/approve technical protocols/reports and prepare/maintain regulatory documentation (e.g., strategies, storyboards, risk assessments).
- Lead global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations) through product lifecycle.
Qualifications:
- BS/BA in scientific discipline; advanced degree (M.S., Ph.D., etc.) required.
- 10+ years biopharmaceutical/device industry experience with 8+ years Regulatory CMC and/or devices experience, leading major submissions (including NDA/BLA/MAA).
- Strong understanding of scientific principles and global regulatory CMC requirements; proven ability to communicate regulatory strategy.
- High attention to detail, ability to assess alternative approaches, and strong written/oral communication.
- Ability to handle critical issues with minimal oversight; good judgment elevating issues to line management.
Benefits (if applicable to location/employment):
- Medical/dental/vision, 401(k) + match, disability and life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, sick time, and paid vacation.
Application instruction:
- By clicking “Apply,” your employment application process begins and your information will be processed per Takeda’s Privacy Notice and Terms of Use.