Director, Regulatory Site CMC
Takeda
June 27, 2026
Remote friendly (Boston, MA)
United States
$177,000 - $278,080 USD yearly
Corporate Functions
Responsibilities:
- Lead site-specific post-approval change management (record evaluations and regulatory submissions, with possible strategic bundling) to ensure compliance with global requirements.
- Use science- and risk-based approaches (ICH Q12) to assess and implement post-approval changes.
- Standardize processes and tools to improve predictability, scalability, and sustainability for site-based regulatory activities.
- Explore and implement automation to increase efficiency and ensure repeatability in change control and submissions.
- Provide centralized regulatory support for multiple manufacturing sites (including external partners) for small molecules and biologics.
- Collaborate with sites/suppliers to align change control with global expectations.
- Evaluate, prioritize, and ensure site compliance using risk and scientific rationale.
- Align site teams with Global Regulatory CMC on post-approval strategy; represent Global Regulatory CMC in Change Review meetings.
- Implement streamlined, digital-enabled workflows to minimize delays.
- Promote sustainable practices and scalability in site-level regulatory operations.
Qualifications/Skills:
- BS/BA in scientific discipline; MS/Ph.D. preferred.
- 10+ years biopharmaceutical/device industry experience; 8+ years direct Regulatory CMC or Regulatory Device experience (e.g., variations/amendments; IND/IMPD; NDA/BLA support).
- Strong practical experience with global HA requirements beyond EU/US.
- Knowledge of scientific principles and global regulatory CMC for drug development and post-market support.
- Proven ability to understand/communicate regulatory strategy to development, registration, and post-market teams.
- Detail-oriented issue analysis; assess alternative approaches; develop strategy recommendations using precedents/intelligence.
- Excellent written/oral communication; leadership, collaboration, negotiation, problem solving; emerging leadership and inclusive mindset.
Benefits (if eligible, U.S.):
- Medical/dental/vision, 401(k) match, disability/life insurance, tuition reimbursement, paid time off, holidays, well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.
- Lead site-specific post-approval change management (record evaluations and regulatory submissions, with possible strategic bundling) to ensure compliance with global requirements.
- Use science- and risk-based approaches (ICH Q12) to assess and implement post-approval changes.
- Standardize processes and tools to improve predictability, scalability, and sustainability for site-based regulatory activities.
- Explore and implement automation to increase efficiency and ensure repeatability in change control and submissions.
- Provide centralized regulatory support for multiple manufacturing sites (including external partners) for small molecules and biologics.
- Collaborate with sites/suppliers to align change control with global expectations.
- Evaluate, prioritize, and ensure site compliance using risk and scientific rationale.
- Align site teams with Global Regulatory CMC on post-approval strategy; represent Global Regulatory CMC in Change Review meetings.
- Implement streamlined, digital-enabled workflows to minimize delays.
- Promote sustainable practices and scalability in site-level regulatory operations.
Qualifications/Skills:
- BS/BA in scientific discipline; MS/Ph.D. preferred.
- 10+ years biopharmaceutical/device industry experience; 8+ years direct Regulatory CMC or Regulatory Device experience (e.g., variations/amendments; IND/IMPD; NDA/BLA support).
- Strong practical experience with global HA requirements beyond EU/US.
- Knowledge of scientific principles and global regulatory CMC for drug development and post-market support.
- Proven ability to understand/communicate regulatory strategy to development, registration, and post-market teams.
- Detail-oriented issue analysis; assess alternative approaches; develop strategy recommendations using precedents/intelligence.
- Excellent written/oral communication; leadership, collaboration, negotiation, problem solving; emerging leadership and inclusive mindset.
Benefits (if eligible, U.S.):
- Medical/dental/vision, 401(k) match, disability/life insurance, tuition reimbursement, paid time off, holidays, well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.