17 days ago
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.
- 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
- 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)