Regulatory Affairs Manager - CMC Biologics
Edison-New Brunswick Metro Area, NJ
BS or Advanced Degree in Scientific Field
Experience with Biologic / Cell Therapy CMC regulatory documents (MAA, BLA, supplements, meeting requests and briefing books responses and IND/CTAs)
Experience with CMC regulations for biological / cell therapy compounds
Experience with Gene/Cell/CAR T Cell therapy CMC regulations
Practical knowledge of FDA, EMEA, Canadian and ICH guidelines.
Must have 5-7years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA, with a minimum of 1-3 years of Biologic / Cell Therapy Regulatory CMC experience, including the preparation of Biologic / Cell Therapy CMC dossiers
Support Regulatory CMC Cell Therapy group in the preparation of submissions. These submissions include briefing books, IND/CTA, BLA, MAA and global cell therapy applications.