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Associate Director - CMC Biologics - Regulatory

Edison-New Brunswick Metro Area, NJ

Posted: 03/04/2019 Job Type: Scientific Job Number: JN -032019-23837
  • 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.
    Qualifications
    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

    Skills/Knowledge Required:
    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
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