Principal Scientist, Regulatory Liaison - Immunology

Role: Principal Scientist, Global Regulatory Liaison, leading worldwide regulatory strategies within Immunology for investigational and marketed biologics. Objectives include optimizing product labeling and securing rapid approvals from global agencies (FDA, EMA). Responsibilities: develop and implement global regulatory plans, advise Product Development Teams, coordinate regulatory submissions (INDs, CTAs, marketing applications), lead interactions with authorities, review clinical and regulatory documentation, and support licensing activities. Qualifications: B.S./M.S. with 7+ years or MD/PhD/PharmD with 5+ years in drug development, with strong regulatory expertise, especially in immunology. Preferred: experience with biologics and small molecules across major markets (U.S., EU, Japan, China). Skills include strategic planning, regulatory submissions, agency negotiations, and cross-functional leadership. High-Value: immunology focus, biologics, global regulatory strategy, IND/CTA submissions, agency interactions, and experience with international markets. Work setup: remote with approximately 10% travel.