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Senior Director, Regulatory Affairs CMC

3 months ago

West Chester, United States Meet Full time

Senior Director, Regulatory Affairs CMC

Hybrid - West Chester, PA

Meet has partnered with a very well-established pharma with hundreds of approved products. They are looking for a Senior Director of Regulatory CMC (biologics) to join their team. This position will be working across the companys mid-stage, new development pipeline and will be reporting into the VP of Regulatory Affairs.

Key Responsibilities

  • Manage the process of maintaining and updating CMC sections of assigned regulatory submissions
  • Identify and evaluate CMC issues related with new product development including product and process development, analytical methods, and manufacturing
  • Manage cross-functional product teams for CMC-related projects, serving as a SME and group leader

Key Qualifications

  • 10+ years of industry experience, 6+ specifically in Regulatory CMC
  • Experience working throughout all phases of development (IND/IMPD through BLA/MAA)
  • Direct people management experience required
  • Biologics background required

Please reach out to Ryan Moran to learn more about this position:

ryan.moran@peoplewithchemistry.com