Principal Scientist, Regulatory Liaison - Immunology

Role: Director (Principal Scientist), Global Regulatory Liaison, leads worldwide regulatory strategies for immunology projects, overseeing product registration, labeling, and approval processes. Responsibilities: serve as the primary regulatory contact, develop and execute global strategies, coordinate submissions with agencies (FDA, EMA), review dossiers and study protocols, and interact independently with regulators. Manage cross-functional teams and support regulatory filings for investigational and marketed biologics. Requirements: B.S./M.S. with 7+ years or PhD/MD with 5+ years in drug development, regulatory affairs, or related fields, with experience in immunology preferred. Skills include strategic regulatory planning, agency interactions, and global submissions. High-Value: immunology therapeutics, biologics, regulatory strategy, global submissions, agency interactions, IND/CTA preparations; 10% travel, remote work possible.