Associate Director - CMC Biologics - Regulatory
Edison-New Brunswick Metro Area, NJ
- Snr Regulatory / CMC Biologics - Assoc. Director
- Assist the Regulatory-CMC Biologics team with projects to support department goals and objectives.
- Job Duties:
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 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
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