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    Senior Regulatory Affairs Scientific Leader - Los Angeles, United States - Clinical Professionals

    Clinical Professionals
    Clinical Professionals Los Angeles, United States

    1 week ago

    Default job background
    Description

    Reference Number:

    JO
    Senior Regulatory Affairs Scientific Leader


    Rate:
    Negotiable


    Job Type:
    Permanent


    Location:
    United States

    Exciting opportunity at a fast-growing biotech


    The team are looking for a regulatory affairs scientific lead that has excellent knowledge and skills in CMC, GMP and regulatory affairs.


    Responsibilities:

    • Lead the implementation of regulatory strategies to handle agency inquiries, oversee product lifecycle management and manage dossier remediation.
    • Provide expert guidance on regulatory strategies, processes, filings, and best practices, with a focus on CMC for NADA products.
    • Display in-depth scientific knowledge and lead the Regulatory CMC Remediation Team.
    • Assess change controls for regulatory impact and manage communications with authorities under Senior US RA Management guidance.
    • Create regulatory documentation for project submissions and stay updated on regulatory changes to advise teams.
    • Assess change controls for regulatory impact and manage communications with authorities under Senior US RA Management guidance.

    Ideal Candidate:

    • Good understanding of GMP requisites, particularly in the domain of chemistry, manufacturing, and controls (CMC).
    • Extensive experience in US regulatory affairs with a specialized focus on CMC.
    • Holds a science degree or other relevant life sciences experience.
    If interested please apply direct or contact:

    #J-18808-Ljbffr
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