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.