Biologics Regulatory Affairs Director
7 days ago
We are seeking a highly skilled Biologics Regulatory Affairs Director to join our team at Takeda. As a key member of our GRA CMC team, you will be responsible for developing and executing regulatory strategies for assigned products.
Responsibilities:- Develops, executes, and oversees regulatory submissions preparation per the GRA CMC Product Team CMC strategy.
- Guides the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirements.
- Represents Takeda GRA CMC in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC-related matters.
- Bachelor's degree in a scientific discipline; advanced degree required.
- 10+ years of overall biopharmaceutical/device industry experience with 8+ years pharmaceutical Regulatory CMC and/or devices experience.
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
$140,000 - $180,000 per year, depending on experience.
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