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    Senior Director, Regulatory Affairs DICE - San Francisco, United States - Advance Global Professionals Inc.

    Advance Global Professionals Inc.
    Advance Global Professionals Inc. San Francisco, United States

    3 weeks ago

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    Description
    Be accountable for leading the development of strategic plans for pipeline assets and implementation.

    Provides leadership on project teams in all areas of regulatory affairs

    Develop regulatory strategies across multiple regulatory activities (CMC, nonclinical, and clinical) to ensure timelines and achievements are met to support the business needs of the company

    Plan, implement, and lead successful regulatory agency meetings and interactions per regulatory strategy

    Define content for and direct the organization and preparation of high quality and effective regulatory submissions, including future applications (e.g., CTA and IND)

    Review and approve clinical study protocols, informed consent forms, statistical analysis plans, clinical study reports, investigator brochures, responses to regulatory agencies and all regulatory submissions

    Serve as regulatory liaison with global health authorities, business partners, and CROs

    Play a key role as a member of the Development Leadership Team

    Understands and maintain knowledge and monitor changes in pertinent laws, regulations and guidances and takes a leadership role in assessing and communicating the impact of these requirements to the business

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    Senior Director, Regulatory Affairs DICE

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