Director, Global Regulatory Affairs CMC
Takeda Pharmaceutical Company(2 months ago)
About this role
The GRA CMC Product Lead at Takeda is a senior regulatory role within the Chemistry, Manufacturing & Controls and Devices organization responsible for shaping and executing global CMC regulatory strategies across development, registration, and post-approval lifecycles. The position represents Takeda in interactions with health authorities and collaborates with cross-functional teams and alliance partners to ensure regulatory compliance and approval of products. The role also contributes to development of regulatory tools, training, and mentorship within the GRA CMC function.
Required Skills
- Regulatory Strategy
- CMC
- Submissions
- Health Authorities
- Leadership
- Communication
- Risk Assessment
- Regulatory Compliance
- Change Control
- Project Management
+1 more
Qualifications
- BS/BA in Scientific Discipline
- Advanced Degree (MS or PhD)
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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