CMC Regulatory Manager
San Diego Metro Area, California
Support Regulatory CMC Biologics group in the preparation of submissions. These submissions include briefing books, IND/CTA, BLAs, MAAs and global biologic applications.
BS, MS, PHD with 7-9 years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA, with a minimum of 5 years of Biologic Regulatory CMC experience, including the preparation of Biologic CMC dossiers. At least a Bachelor Degree required. Master s Degree or PhD preferred
Extensive experience with Biologic CMC regulatory documents (MAA, BLA, supplements, meeting requests and briefing books responses and IND/CTAs)
Experience with CMC regulations for biological compounds
Practical knowledge of FDA, EMEA, Canadian and ICH guidelines.
Practical knowledge of rest of world post approval guidelines
Have a solution-oriented approach to problem solving
Expertise in the drug development process and post approval activities
Ability to work on complex projects and within cross-functional teams