Principal Scientist, Regulatory Liaison - Immunology

Role: Lead global regulatory strategy for immunology-focused investigational and marketed biologics/drugs, ensuring efficient approval timelines and optimized labeling. Responsibilities: develop worldwide regulatory plans, serve as the primary regulatory contact for product teams, liaise with agencies (FDA, EMA), prepare submissions (INDs, CTAs, marketing applications), review study protocols and reports, and coordinate regional strategies with affiliates. Requirements: B.S./M.S. with 7+ years or M.D./PhD/PharmD with 5+ years in drug development, with substantial regulatory experience; proven ability in global filings and agency interactions. HighValue: immunology therapeutics, biologics, global regulatory submissions, IND/CTA preparation, agency negotiations, cross-regional collaboration. WorkSetup: remote with approximately 10% travel; reports to ED, General Medicine.