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Job

VP of Regulatory Affairs

  • Location

    New York City

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Marin Haugo

  • Contact email:

    m.haugo@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Job ref:

    REF-5

  • Published:

    2 months ago

  • Expiry date:

    2022-08-06

  • Startdate:

    ASAP

  • BLA experience is essential  
  • Strategic with health authorities, the company has a product going through BLA filing/ commercialization this year and they need someone who understands this process and has direct experience with FDA and other authorities 
  • A minimum of 10 years of pharmaceutical and drug development regulatory experience, as well as a background in dealing with the FDA and preferably European regulatory authorities in US-based Pharma/Biotech, is required for this position. 
  • Experience working in a small biotech environment
  • Experience in both oncology/non-oncology drug development is preferred, though not required.
  • Substantial experience in all aspects of regulatory affairs, including Commercial support, CMC, and Clinical, with a track record of successful submissions and license approvals with CDER or CBER
  • Extensive knowledge of clinical development, FDA and international global clinical trial regulations and relevant requirements
  • A demonstrated ability to manage regulatory activities and deliver against program timelines
  • Exceptional qualitative and analytical/quantitative skills
  • Demonstrates outstanding leadership capabilities, ability to
  • Works with diverse stakeholders and builds strong, collaborative relationships
  • Exceptional verbal and written communication skills
  • Excellent organizational, interpersonal, communication, and negotiation skills
  • RAC certification is helpful but not necessary
  • Radiopharmaceutical experience is a bonus/preferred but not essential

Education

  • A PharmD or PhD degree in a scientific discipline