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Job

Director, Regulatory Affairs

  • Location

    New Jersey

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Adele McKenna

  • Contact email:

    a.mckenna@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    16 days ago

  • Expiry date:

    2020-12-11

  • Startdate:

    ASAP

Hamlyn Williams has partnered with an exciting Pharmaceutical company, based in New Jersey, in their search for a Director of Regulatory Affairs. Our client seeks a candidate who will support a variety of regulatory projects, primarily focused in novel therapies in the oncology space. 

Job Description:

  • You will be responsible for serving as the global regulatory lead
  • Responsible for developing global regulatory strategies
  • Coordinateing and overseeing regulatory interactions globally 
  • Leading submission teams for regulatory submissions such as: INDs, BLAs and CTAs
  • Keeping current with, review and interpret regulations and guidelines

Qualifications:

  • A BS degree n a related scientific discipline
  • 10+ years of pharmaceutical industry experience         
  • 5+ years of experience with global regulatory affairs 
  • Filing to FDA experience, such as: NDA, sNDA and BLa is a plus

 

Apply here or email a.mckenna@hamlynwilliams.com if you are interested in working with a leading organization in the industry.