Senior Director, Regulatory Affairs

Role Senior Director of Regulatory Affairs overseeing global regulatory strategies for biologics development, with a focus on late-stage filings. Responsibilities lead IND, BLA, sBLA submissions develop regulatory scientific and tactical strategies liaise with FDA, EMA, MHRA oversee regulatory documentation including CTDs, briefing documents, labeling provide leadership within cross-functional development teams, including mentoring direct reports ensure compliance with global regulatory requirements contribute to procedures for late-stage development and commercialization manage health authority interactions and review clinical trial labeling and CMC submissions Requirements advanced degree (MS, PharmD, PhD, MD) with 8-12 years' (MS) or 10-15 years' (BS) experience extensive knowledge of US and global regulatory environments proven experience in preparing IND/CTA, BLA/NDA submissions, including at least one NME BLA/NDA strong leadership, communication, and interpersonal skills experience in biologics, late-stage development, and health authority meetings HighValue biologics late-stage development global regulatory submissions FDA interactions IND/BLA filings regulatory strategy development WorkSetup roles based in Gaithersburg, MD or Radnor, PA, with potential for global interaction and oversight. #J-18808-Ljbffr Scorpion Therapeutics