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 (small molecule) 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)
• Small molecule background highly preferred

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

ryan.moran@peoplewithchemistry.com