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    Vice President Regulatory Affairs - Boston, United States - Meet Recruitment

    Meet Recruitment
    Meet Recruitment Boston, United States

    3 weeks ago

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    Description
    VP or SVP Regulatory Affairs

    opportunity with an Oncology focused biotech in the Boston area

    Responsibilities:
    Build and drive Regulatory department/function by providing expert strategic insights and solutions toward successful product approvals.

    Develop and implement robust regulatory strategy and provide operational support across all clinical programs, while adhering to applicable US and ex-US regulatory, compliance, and quality standards.

    Prepare and deliver successful submissions/filings and outcomes with health authorities by providing effective leadership, oversight, direction, and planning.
    Develop timelines, milestones, and budgets in order to track progress, identify risks/constraints, and propose effective solutions for clinical programs.

    Prepare and contribute to reports and regulatory submissions, including identification and mitigation of potential critical issues, regulatory risks, to support decision-making on all product candidates.

    Work cross-functionally with various teams (CMC, Clinical, external consultants, etc.) to ensure regulatory plans are established and align with company objectives.


    Qualifications:
    Advanced degree in life science related field with 12+ years in the biotechnology industry.
    Experience in an Executive level role, working with C-suite personnel.
    Oncology experience required.
    Proven experience leading major Regulatory submissions including CTA, BLA, etc.
    Ability to effectively liaise cross-functions with internal/external stakeholders, partners, vendors.
    Advanced working knowledge of the US Regulatory landscape including regulatory, compliance, and quality guidelines for oncology programs.
    For full details on this opportunity, reach out to Kasey Dillon on or

    #J-18808-Ljbffr


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