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Job

Director - Regulatory Affairs Strategy

  • Location

    Boston, Massachusetts

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Ryan Burton

  • Contact email:

    r.burton@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Job ref:

    HQ00011110

  • Published:

    about 1 month ago

  • Expiry date:

    2020-11-19

  • Startdate:

    11/1/2020

Hamlyn Williams has partnered with a reputable gene therapy pharmaceutical company and industry leader for the recruitment of a director, regulatory affairs strategy for their Massachusetts location. This is an exciting opportunity for anyone who is looking for a move to an innovative biotech/pharmaceutical company at director, either laterally or as a step up from Associate Director level.

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 6 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)

Apply here or email r.burton@hamlynwilliams.com if you are interested in working with a leader in the biopharma space.