Director, Regulatory Strategist

Role: Lead global/regional regulatory strategies and implementation for complex biopharma products, including novel and post-approval assets. Responsibilities: develop and monitor regulatory plans, prepare submission dossiers, collaborate with cross-functional teams (Clinical, Safety, Medical, GCMC, Quality, R&D, Commercial, Legal), ensure compliance, and engage with health authorities. Provide regulatory input to clinical development and labeling, support business development due diligence, and drive regulatory system improvements. Qualifications: B.S. in science; 8+ years of US, EU, EM regulatory experience; global/regional expertise; deep knowledge of regulatory environment; proven success managing diverse product lifecycles and negotiations with health authorities. Preferred: advanced scientific or business degrees (Ph.D., Pharm.D., M.D., M.Sc., MBA, DMS), regulatory certification, strong strategic and communication skills. High-Value: experience in regulated biopharma products, including novel, post-approval, or lifecycle management; exposure to global regulatory agencies; hybrid work setup with 2 days/week in DC office; travel may be required. Salary range: $112,000–$236,000.