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Job

Executive Director- Regulatory Affairs

  • Location

    New Jersey

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact email:

    a.mcgarel@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Job ref:

    AMRA01

  • Published:

    2 months ago

  • Expiry date:

    2020-09-20

  • Startdate:

    ASAP

My client are an Oncology focussed Clinical Stage Biotech searching for a Regulatory Affairs leader to build the division and act as liaison to the FDA and other international regulatory bodies. Reporting to the Global VP of Clinical Development this individual will be tasked with building out the Global Regulatory function for this exciting Clinical Stage Biotech and gaining regulatory approvals on an exciting and varied pipeline of Oncology products. 


Key Requirements:

  • 15 + years of experience in US Regulatory affairs  interacting and liaising directly with the FDA
  •  
  • Ph.D. or Advanced degree highly preferred
  • Deep knowledge of regulatory requirements within the Drug/ Biologics space.

  • Experience in filing IND/ BLA's

  •  5+ years of experience supervising various regulatory staff cross-functionally

  •  Experience in various regulatory submissions and communication with regulatory agencies.

 
If this position seems of interest or you know of someone who may be a good fit feel free to reach out directly a.mcgarel@hamlynwilliams.com .