Snr Regulatory CMC Biologics Specialist
Edison-New Brunswick Metro Area, NJ
- Support Regulatory CMC Biologics group in the preparation of submissions. These submissions include briefing books, IND/CTA, BLA, MAA and global biologic applications.
Must have 5-7 years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA, with a minimum of 1-3 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
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
Experience with Gene/Cell/CAR T Cell therapy CMC regulations
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