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CMC Regulatory Affairs Associate

Newark Metro Area, NJ

Post Date: 03/06/2018 Job ID: JN -032018-21077 Job Type: Scientific
  • Support Regulatory CMC Biologics group in the preparation of regulatory submissions.
  • Submissions include briefing books, IND/CTA, BLA, MAA and global biologic applications.
    Qualifications
    Must have 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
    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.

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