Senior Director, Regulatory Affairs

RoleSenior Director of Regulatory Affairs overseeing global regulatory strategies for biologics development, with a focus on late-stage filings. Responsibilitieslead 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 Requirementsadvanced 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 HighValuebiologics late-stage development global regulatory submissions FDA interactions IND/BLA filings regulatory strategy development WorkSetuproles based in Gaithersburg, MD or Radnor, PA, with potential for global interaction and oversight.