Los Angeles, CA
over 1 year ago
The Associate Director of CMC Regulatory Affairs serves as the global product leader for CMC regulatory strategy of one or more biological and/or small molecule products. This includes the formulation and implemention of global CMC regulatory strategies for the development of protein therapies, and lead CMC regulatory activities for assigned projects in line with global requirements. The AD will serve as a liaison between the regulatory authorities and the company on CMC issues, provide CMC RA leadership within RA and on cross-functional CMC teams, and maintain up-to-date knowledge and expertise of relevant FDA and ICH guidelines and regulations. Located in Los Angeles, California.
- B.S / M.S / Pharm. D. or Ph.D. in biochemistry, biology, engineering or related pharmaceutical field
- At least 7 years of drug development/pharmaceutical industry experience including significant strategic experience
- 5+ years in CMC regulatory affairs with a small molecule and/or biologics background.
- Demonstrated leadership in regulatory strategy and experience in regulatory interactions
If interested apply immediately as this is a fantastic opportunity with a globally recognized pharmaceutical company.