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Job

Senior Director - Regulatory Affairs Strategy - Remote

  • Location

    Remote

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Ryan Burton

  • Contact email:

    r.burton@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    17 days ago

  • Expiry date:

    2021-11-10

  • Startdate:

    10/25/2021

Hamlyn Williams has partnered with a reputable, clinical-stage oncology-focused pharmaceutical company and industry leader for the recruitment of a fully remote, Senior Director-level Regulatory Strategy professional. This is an exciting opportunity for anyone who is looking for a move to an innovative biotech/pharmaceutical company, part of a $7B market cap , global organization.

Role:

  • Develop the regulatory affairs strategy in accordance with the companies goals and objectives
  • Liaise/negotiate directly with the FDA and other regulatory bodies whilst leading the submissions of MMAs, NDAs, INDs, and BLAs (both US and foreign)
  • Advise CMC function on the preparation and content of IMPDs, NDAs, INDs and BLAs.
  • Lead the planning, strategy, content and execution of BLA and MAA filing and approval
  • Provide training and presentations to internal regulatory affairs functions
  • Provide guidance and leadership to junior RA strategy professionals

Requirements:

  • PharmD, PhD and/or M.S. required
  • A minimum of 8 years of experience within regulatory affairs in both a pre-clinical and post-commercialization environment
  • Strong technical writing ability
  • Experience in preparing regulatory submissions but domestically and globally (CTA, IND, BLA, MAA)

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