Director, Global Regulatory Affairs CMC
Takeda
21 days ago
Remote friendly (Boston, MA)
United States
$177,000 - $278,080 USD yearly
Corporate Functions
Responsibilities:
- Independently develop and execute regulatory CMC investigational, registration, and post-approval strategies for assigned products; may serve as GRA CMC Product Lead.
- Lead major CMC aspects of global registrational submissions for complex drug product/suites.
- Represent cross-functional teams (Regulatory, Pharmaceutical Development, Commercial) across clinical development and commercial lifecycle.
- Provide expert leadership and apply GRA CMC regulations/guidelines to improve regulatory success and compliance.
- Develop and oversee major global registrational submissions and guide CMC dossier strategy/content; review for conformance.
- Represent Takeda in Health Authority meetings (CMC-related), and prepare/guide required meeting activities.
- Review/approve technical protocols, reports, and regulatory documentation (e.g., technical regulatory strategy, storyboards, risk assessments) as applicable.
- Lead assigned submissions (e.g., INDs, CTAs, BLAs, MAAs, Variations, Core Dossiers) through product lifecycle.
- Support change controls, deviations, investigations; identify and communicate CMC regulatory risks.
- Provide tactical regulatory guidance; mentor/coach other GRA CMC members.
Minimum Requirements/Qualifications:
- BS/BA in a scientific discipline; MS/Ph.D. required.
- 10+ years biopharmaceutical/device industry experience; 8+ years Regulatory CMC and/or devices experience, including leading major submissions (e.g., NDA/BLA/MAA).
- Strong understanding of scientific principles and regulatory CMC requirements for global development/post-market support.
- Proven ability to understand/communicate regulatory strategy; strong written/oral communication.
- Analytical/process understanding; attention to detail; good judgment with minimal oversight.
Benefits (explicitly listed):
- Medical/dental/vision, 401(k) with match, disability/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).
Application instructions:
- Apply via Takeda’s online application (“Apply” button).
- Independently develop and execute regulatory CMC investigational, registration, and post-approval strategies for assigned products; may serve as GRA CMC Product Lead.
- Lead major CMC aspects of global registrational submissions for complex drug product/suites.
- Represent cross-functional teams (Regulatory, Pharmaceutical Development, Commercial) across clinical development and commercial lifecycle.
- Provide expert leadership and apply GRA CMC regulations/guidelines to improve regulatory success and compliance.
- Develop and oversee major global registrational submissions and guide CMC dossier strategy/content; review for conformance.
- Represent Takeda in Health Authority meetings (CMC-related), and prepare/guide required meeting activities.
- Review/approve technical protocols, reports, and regulatory documentation (e.g., technical regulatory strategy, storyboards, risk assessments) as applicable.
- Lead assigned submissions (e.g., INDs, CTAs, BLAs, MAAs, Variations, Core Dossiers) through product lifecycle.
- Support change controls, deviations, investigations; identify and communicate CMC regulatory risks.
- Provide tactical regulatory guidance; mentor/coach other GRA CMC members.
Minimum Requirements/Qualifications:
- BS/BA in a scientific discipline; MS/Ph.D. required.
- 10+ years biopharmaceutical/device industry experience; 8+ years Regulatory CMC and/or devices experience, including leading major submissions (e.g., NDA/BLA/MAA).
- Strong understanding of scientific principles and regulatory CMC requirements for global development/post-market support.
- Proven ability to understand/communicate regulatory strategy; strong written/oral communication.
- Analytical/process understanding; attention to detail; good judgment with minimal oversight.
Benefits (explicitly listed):
- Medical/dental/vision, 401(k) with match, disability/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).
Application instructions:
- Apply via Takeda’s online application (“Apply” button).