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Scientific. Clinical. Software Engineering

Regulatory Affairs Manager - CMC Biologics

Edison-New Brunswick Metro Area, NJ

Job Type: Scientific Job Number: JN -042020-26703 Region: Edison-New Brunswick Metro Area

Job Description

Requirements:

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

Responsibilities:


Job Duties

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.

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