Connecting linkedin

W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9oyw1sew4td2lsbglhbxmvanbnl2jhbm5lci1kzwzhdwx0lwpvyi5qcgcixv0

Job

Director, Regulatory Affairs

  • Location

    New York, New York

  • Sector:

    Life Sciences

  • Contact:

    Adele McKenna

  • Contact email:

    a.mckenna@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 1 month ago

  • Expiry date:

    2020-11-20

Hamlyn Williams has partnered with an exciting Pharmaceutical and Medical Device company in their search for a Director of Regulatory Affairs. Our client seeks a candidate who will support a variety of regulatory projects from development through post-approval. This client is publically traded and located in New York City.

 

Job Description:

  • You will be responsible for the implementation of regulatory strategies for medical device products and ensuring those activities maintain consistency within said regulatory strategy
  • Regulatory project management and oversight of documentation for both new and ongoing global clinical oncology trials
  • Ensure regulatory continuous compliance with FDA
  • Prepare, review and submit domestic and international regulatory submissions including: NDA, IND and CTA
  • Responsible for IND reports as well as annual and supplemental reports to the FDA for both INDs and NDAs
  • Review programs and provide Regulatory Affairs SOPs
  • Resolve any regulatory compliance issues

 

Qualifications:

  • A BS or MS in life or physical sciences is required. An MBA, additionally, is a plus.
  • 7-10+ years of regulatory affairs oncology experience in the pharmaceutical industry
  • Direct experience within Regulatory Affairs clinical trial conduct

 

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