Associate Director, Regulatory Affairs CMC

Location: San Diego, CA

Type: Permanent Position 

Salary: Competitive

My clinical stage biotech client in San Diego dedicated to addressing the genetic causes of cancer is looking to hire a new Associate Director, Regulatory Affairs CMC. The Associate Director, Regulatory Affairs will report into the VP, Regulatory affairs CMC and will be responsible for preparing and overseeing the preparation of submissions and developing the regulatory CMC strategy. They are looking for someone with prior experience preparing CMC regulatory submissions and responding to health authority queries. 

Responsibilities: 

• Maintain compliance with regulatory requirements when preparing regulatory dossiers (e.g. IND, IMPD, NDA, and MAA) for submissions to global Health Authorities
• Analyze and assess US and international regulations and guidance
• Acts as Regulatory CMC Lead
• Respond to health authority queries regarding regulatory CMC strategy
• Responsible for the development of global CMC regulatory strategies for analytical, chemical, and product development

Requirements: 

• Bachelor's degree or higher biological or physical sciences
• Knowledge of US FDA and international pharmaceutical regulations and drug development processes.
• Experience developing CMC regulatory Strategy

I am a Regulatory Affairs market expert working with a large variety of clients across the Biotech and Pharmaceutical industries. If this role isn’t of interest to you, but you’d like to explore other opportunities in the market, please feel free to reach out directly. Contact Nikita Madan at 619-350-6341 or at n.madan@hamlynwilliams.com