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Job

Head of Regulatory Affairs

  • Location

    New York

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    $180,000- $200,000

  • Contact:

    Marissa Saunders

  • Contact email:

    m.saunders@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    9 months ago

  • Expiry date:

    2020-02-28

A commercialized Biotech client of ours in the rare disease space is looking for a Director of Regulatory Affairs to handle the regulatory affairs efforts for the organization. This position will report directly into the Head of R&D.

Responsibilities:

  • File IND's, NDA's, and ensure compliance for their commercialized products
  • Lead the Regulatory Affairs division and sit on the leadership team of the company
  • Be responsible for post-approval and investigational regulatory submissions to the FDA
  • Be responsible for submissions to foreign regulatory authorities such as the EMA
  • Be the primary for approval responsibility of regulatory review for advertising and promoted materials of the company's commercialized products 
  • Chair the promotional review committee
  • Serve as the primary contact with the FDA Office of Prescription Drug Promotion 
  • Collaborate cross functionally with other important stakeholders such as marketing, legal, and medical affairs
  • Provide regulatory guidance in the preparation and creation of all regulatory documents 

Requirements:

  • 5-7 years of experience for review and approval of promotional and advertising materials for a US pharmaceutical company 
  • Demonstrated success for INDA and NDA regulatory submissions
  • Bachelor's or other professional degree related to the pharmaceutical industry such as biology, chemistry, law, etc. 
  • Ability to work in a team environment 
  • Ability to work with computer systems to create and submit regulatory submissions 

This role is actively interviewing, so if interested please feel free to contact Marissa at m.saunders@hamlynwilliams.com