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Snr Regulatory CMC Biologics Specialist

Edison-New Brunswick Metro Area, NJ

Posted: 07/10/2018 Job Type: Scientific Job Number: JN -072018-22009
  • Support Regulatory CMC Biologics group in the preparation of submissions. These submissions include briefing books, IND/CTA, BLA, MAA and global biologic applications.
    Qualifications
    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

    Skills/Knowledge Required:
    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

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