about 1 month ago
Hamlyn Williams has partnered with a reputable gene therapy biotech company and industry leader, for the recruitment of a Vice President, Regulatory Affairs strategy to be based remotely, with no plans of going back into their New York office. This is an exciting opportunity for anyone who is looking for a move to an innovative biotech/pharmaceutical company at VP, either laterally or as a step up from Senior/Executive Director level.
- Provide leadership and development of 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
- Act as a strategic partner to the company's board
- PharmD, PhD and/or M.S. strongly preferred
- A minimum of 10 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 email@example.com if you are interested in working with a leader in the biopharma space.