Senior Director, Regulatory Affairs

Role: Senior Director of Regulatory Affairs responsible for leading global regulatory strategies and submissions for biologics development programs, with a focus on late-stage development. Responsibilities: develop and execute regulatory scientific and tactical plans, manage IND/CTA, BLA/sBLA, MAA submissions, oversee agency interactions including FDA, EMA, and MHRA, and ensure compliance with global regulatory requirements. Lead cross-functional teams, provide regulatory guidance, and mentor direct reports. Requirements: advanced degree (MS, PharmD, Ph.D., or MD) with 8-15 years’ experience in drug regulation, strong expertise in biologics, extensive US regulatory submission experience, and proven leadership skills. HighValue: biologics, late-stage development, IND/BLA filings, global regulatory strategy, FDA interactions, leadership in regulatory sciences, experience supporting clinical studies and preparing for health authority meetings. WorkSetup: roles based in Gaithersburg, MD or Radnor, PA, with a high-profile, fast-paced environment requiring agility and strategic influence.