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Job

Executive Director - Regulatory Affairs Strategy (CRO)

  • Location

    New Jersey - Remote

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Ryan Burton

  • Contact email:

    r.burton@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    26 days ago

  • Expiry date:

    2021-09-29

  • Startdate:

    9/30/2021

Hamlyn Williams is partnered with a full-service CRO providing Phase 1-5 clinical development services to Biotech, Pharma, and Med Device companies. The organization is looking to hire a Regulatory Strategy leader at the Executive Director level - The role will be fully remote, with travel once per quarter.

Duties:

  • Advise clinical project teams on the development and implementation of regulatory strategy
  • Active submission of IND, NDA, CTA, MAAs
  • Liaising with US FDA
  • Provide strategic guidance to Clinical Operations, Medical Writing, Clinical Safety, Data Management, and Biostats teams
  • Provide Senior level regulatory leadership to both external clients and the internal regulatory team

Requirements:

  • Experience with IND, NDA, CTA, MAA submissions is essential
  • 8 years+ regulatory experience in a CRO, consulting company, or Pharmaceutical organization
  • Advanced Life Sciences Degree

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