Principal Scientist, Regulatory Liaison - Immunology

Role: Lead global regulatory strategist for Immunology projects, responsible for developing and implementing worldwide regulatory pathways to optimize labeling and accelerate approvals. Responsibilities: act as the single point of contact for assigned products across development and lifecycle stages; coordinate submissions, interactions with agencies (FDA, EMA), and regional teams; review regulatory documents including marketing applications, clinical reports, and protocols; and guide cross-functional teams on regulatory strategy. Requirements: B.S./M.S. with 7+ years or PhD/MD/PharmD with 5+ years in drug development, with strong regulatory experience, especially in immunology; proven expertise in global filings and agency interactions; excellent communication and strategic thinking skills. HighValue: immunology, biologics or small molecules, global regulatory strategy, IND/CTA preparation, experience with FDA and EMA. WorkSetup: remote with 10% travel.