Director, Regulatory Site CMC
Takeda
August 09, 2026
Remote friendly (Boston, MA)
United States
$177,000 - $278,080 USD yearly
Corporate Functions
About the role:
- Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level across small molecules, biologics, and external manufacturing sites, using an agile approach and ICH Q12 principles, including automation to improve predictability and repeatability.
How you will contribute:
- Lead site-specific post-approval change management (record evaluations and regulatory submissions, considering strategic bundling) to ensure compliance with global requirements.
- Apply science- and risk-based approaches to assess and implement post-approval changes (ICH Q12).
- Standardize processes/tools to improve predictability, scalability, and sustainability.
- Explore and implement automation technologies for repeatable change control and submissions.
- Provide centralized regulatory support for multiple manufacturing sites and external partners (small molecules and biologics).
- Collaborate with sites/suppliers to align change control with global regulatory expectations.
- Evaluate/prioritize changes based on risk and scientific rationale to ensure global regulatory compliance.
- Align site teams with global Regulatory CMC; represent Regulatory CMC in cross-functional Change Review meetings.
- Implement streamlined workflows using digital tools/automation to minimize delays.
- Promote sustainable practices and scalability in site-level regulatory operations.
Minimum Requirements/Qualifications:
- BS/BA in a scientific discipline; advanced degree (M.S., Ph.D., etc.) preferred.
- 10+ years biopharmaceutical/device experience; 8+ years direct Regulatory CMC or Regulatory Device experience (e.g., major variation/amendment, IND/IMPD, NDA/BLA support).
- Strong practical experience with global HA requirements beyond EU/US.
- Understanding of scientific principles and regulatory CMC requirements for global drug development and post-market support.
- Proven ability to develop and communicate regulatory strategy for drug development, registration, and post-market support.
- Excellent written/oral communication; strong leadership, collaboration, negotiation, problem-solving, and teamwork.
Application instructions:
- Apply via the “Apply” button (application processing subject to Takeda Privacy Notice and Terms of Use).
- Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level across small molecules, biologics, and external manufacturing sites, using an agile approach and ICH Q12 principles, including automation to improve predictability and repeatability.
How you will contribute:
- Lead site-specific post-approval change management (record evaluations and regulatory submissions, considering strategic bundling) to ensure compliance with global requirements.
- Apply science- and risk-based approaches to assess and implement post-approval changes (ICH Q12).
- Standardize processes/tools to improve predictability, scalability, and sustainability.
- Explore and implement automation technologies for repeatable change control and submissions.
- Provide centralized regulatory support for multiple manufacturing sites and external partners (small molecules and biologics).
- Collaborate with sites/suppliers to align change control with global regulatory expectations.
- Evaluate/prioritize changes based on risk and scientific rationale to ensure global regulatory compliance.
- Align site teams with global Regulatory CMC; represent Regulatory CMC in cross-functional Change Review meetings.
- Implement streamlined workflows using digital tools/automation to minimize delays.
- Promote sustainable practices and scalability in site-level regulatory operations.
Minimum Requirements/Qualifications:
- BS/BA in a scientific discipline; advanced degree (M.S., Ph.D., etc.) preferred.
- 10+ years biopharmaceutical/device experience; 8+ years direct Regulatory CMC or Regulatory Device experience (e.g., major variation/amendment, IND/IMPD, NDA/BLA support).
- Strong practical experience with global HA requirements beyond EU/US.
- Understanding of scientific principles and regulatory CMC requirements for global drug development and post-market support.
- Proven ability to develop and communicate regulatory strategy for drug development, registration, and post-market support.
- Excellent written/oral communication; strong leadership, collaboration, negotiation, problem-solving, and teamwork.
Application instructions:
- Apply via the “Apply” button (application processing subject to Takeda Privacy Notice and Terms of Use).