Director, Regulatory Strategist

Role: Lead global/regional regulatory strategy development and implementation for complex biopharma projects, including novel, post-approval, and product enhancement initiatives. Responsibilities: partner with cross-functional teams (Clinical, Safety, Medical, Quality, Commercial, Legal), prepare regulatory submissions (INDs, NDAs, MAAs), develop and maintain regulatory plans, ensure compliance with evolving global regulations, contribute to labelling and risk assessments, manage agency interactions, and support business development due diligence. Qualifications: B.S. in a scientific field required; advanced degrees (Ph.D., Pharm.D., M.D., M.Sc.) and/or an MBA preferred. Minimum 8 years of US/EU/EM regulatory experience, with at least 5 years of global/regional regulatory expertise. Proven success in managing complex regulatory activities across product lifecycle stages, negotiating with health authorities, and leading cross-functional collaboration. Skills: deep knowledge of regulatory environment, strategic thinking, strong communication, and experience with global agencies. High-Value: experience in regulated biopharma, familiarity with drug development, post-marketing activities, and global health authority engagement. Work Setup: hybrid role based in DC office, requiring onsite presence two days per week; occasional travel may be needed.