Senior Director, Regulatory Affairs CMC
- Military veterans preferred
2024-05-15 AppCast (https://www.appcast.io)
Other
/yr
full-time
employee
Philadelphia Pennsylvania 19117 United States
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:
