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    Senior Director Regulatory Affairs - Boston, United States - EPM Scientific

    EPM Scientific
    EPM Scientific Boston, United States

    3 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Title: Senior Director, Clinical Regulatory Affairs

    Salary: $250,000 to $285,000

    Summary:

    A clinical-stage biopharmaceutical client of ours is seeking a very experienced and motivated person to fill their Senior Director of Clinical Regulatory Affairs role in their facility located in the greater Boston area. The main functions of this person will be formulating regulatory strategies for both non-clinical and clinical domains, as well as spearheading engagements with regulatory bodies. This role will also give you a great opportunity to contribute to the clients' main missions which is to discover, develop, and commercialize therapies using their antibody technology.

    The Senior Director will be responsible for...

    • Developing and executing regulatory strategies aimed at securing and sustaining clinical trial applications
    • Providing teams with regulatory guidance and input
    • Supervising the development and submissions of regulatory filings within the defined scope of duties
    • Remain up to date on any current regulations and guidance

    The Senior Director should have the following qualifications:

    • Bachelor's degree in life science related field; advanced degree in biomedical sciences or related fields is preferred
    • Minimum of 10 years of experience in biopharmaceutical industry; 5 years of direct experience in regulatory strategy
    • Experience in autoimmune disease
    • Proven success with regulatory submissions such as IND, CTA, MAA, NDA, BLA
    • Vast knowledge of regulatory guidelines of FDA, ICH, EMA, EU NCAs and other international agencies


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