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    Sr. Director, Clinical Regulatory Affairs - Waltham, United States - ClinCrowd

    ClinCrowd
    ClinCrowd Waltham, United States

    5 days ago

    Default job background
    Pharmaceutical / Bio-tech
    Description
    • Minimum 10 years of experience in the biopharmaceutical industry and 5 years of direct experience in a regulatory strategy role required
    • Experience supporting clinical development teams in the autoimmune disease space is a must
    • Provides regulatory guidance and input to project teams
    • Designs and implements regulatory strategies to obtain and maintain clinical trial applications
    • Oversees the creation and submission of all regulatory filings
    • Extensive knowledge of non-clinical and clinical development, regulatory guidelines of FDA, ICH, EMA, EU NCAs, MHRA and other international regulatory agencies
    • Demonstrated track records of successful regulatory meetings, IND or BLA submissions and approvals
    • Experience in Oncology and Immuno-oncology is preferred but not required
    • Arranges for and leads meetings with global health authorities as needed
    • Provides training and mentorship to regulatory staff and other junior staff at the company


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