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.