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    Associate Director Regulatory Affairs CMC - Cambridge, United States - PSG Global Solutions

    PSG Global Solutions
    PSG Global Solutions Cambridge, United States

    3 weeks ago

    Default job background
    Description
    We're looking for an

    Associate Director Regulatory Affairs CMC , working in

    Pharmaceuticals

    and

    Medical Products

    industry in

    Cambridge, Massachusetts, United States .


    Leads development and execution of robust global regulatory CMC strategy for assigned program(s) with balanced risk-based approach using scientific rationale and in alignment with regulatory guidance,working in collaboration with cross-functional CMC and Global Regulatory Teams to achieve program and company goals.

    Leads preparation, including driving strategy and content of high quality regulatory submission content focusing on chemistry, manufacturing, and control (CMC) to support global clinical development, registration, and product life cycle management
    Manages timely regulatory submissions that involve CMC components including CTAs/INDs, NDA/MAA, and agency meeting packages.
    Provides support to regulatory interactions on CMC related topics.
    Actively participates in RA CMC infra-structure and capability.

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