Director, Regulatory Site CMC
Takeda Pharmaceutical Company(2 months ago)
About this role
The Director, Regulatory Site CMC leads site-level management of regulatory change control and post-approval activities for small molecules, biologics, and external manufacturing partners. The role drives standardization and scalability using ICH Q12 principles and explores automation to improve predictability and repeatability. The position communicates regulatory strategy across development, registration, and post-market teams to ensure global compliance.
Required Skills
- Regulatory Strategy
- Change Control
- Post-Approval
- ICH Q12
- Automation
- Risk Assessment
- Stakeholder Alignment
- Global Regulations
- Communication
- Leadership
+3 more
Qualifications
- BS in Scientific Discipline
- MS or PhD Preferred
About Takeda Pharmaceutical Company
takeda.comTakeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.
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