Director of Regulatory Affairs,Tactical and Implementation

Role: Lead and oversee the global Regulatory Tactical Implementation team within Regulatory Affairs, focusing on biologics development. Objectives include standardizing processes for efficiency, supporting early and late-stage regulatory filings, and ensuring compliance across US and international authorities. Responsibilities encompass guiding regulatory strategy implementation, managing IND, BLA/sBLA submissions, liaising with agencies, and overseeing tactical execution of global regulatory submissions. The role involves mentoring staff, resource planning, and maintaining regulatory intelligence to adapt to evolving laws and guidelines. Requirements include an advanced degree (M.S., PharmD, Ph.D., or M.D.) with a minimum of 5 years (or a BS with 8-10 years) of experience in drug development, particularly in biologics. Experience with global regulatory submissions (INDs, BLAs, NDAs), health authority interactions, and supporting clinical studies is essential. Preferred qualifications include prior involvement in NME BLA/NDA submissions and Health Authority meetings. The candidate should demonstrate leadership, cross-functional collaboration, agility, and regulatory expertise in biologics, ideally with global experience. The position involves supervising regulatory staff, providing strategic input, and working in a dynamic, innovative environment. Location is in Gaithersburg, MD, or Radnor, PA, with potential for remote work; travel requirements are not specified.