Biologics Regulatory Affairs Director

2 days ago


Cambridge, Massachusetts, United States Takeda Full time
Job Summary

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.
Requirements:
  • 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.
Salary Range:

$140,000 - $180,000 per year, depending on experience.



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