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Job

Associate Director, Regulatory Affairs

  • Location

    New Jersey

  • Sector:

    Life Sciences

  • Contact:

    Adele McKenna

  • Contact email:

    a.mckenna@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    15 days ago

  • Expiry date:

    2020-12-12

  • Startdate:

    Immediate

Hamlyn Williams has partnered with an exciting Pharmaceutical company, based in New Jersey, in their search for an Associate 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 managing CMC development and post marketing 
  • Responsible for developing and executing strategy and submissions 
  • Leading health authority interactions for both the US and EU interactions 

Qualifications:

  • A MS/PhD degree in a related scientific discipline
  • 8+ years of pharmaceutical industry experience         
  • 4+ years of CMC experience
  • Experience with preperation, management and review of filings such as: NDA, MAA and BLA with both the FDA and EMA 

 

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