Senior Director, Regulatory Affairs CMC
2 weeks ago
Senior Director, Regulatory Affairs CMC
Hybrid - Philadelphia, 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 company's 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 NDA/MAA)
- Biologics background highly preferred
Please reach out to Ryan Moran to learn more about this position:
ryan.moran@peoplewithchemistry.com
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