Sr. Principal Scientist (Sr. Director) - Regulatory Liaison

Role: Senior Principal Scientist, Regulatory Affairs Liaison, leading global regulatory strategies for cardiovascular metabolic programs within General Medicine. Responsibilities: develop and execute regulatory plans to optimize labeling and expedite approvals for multiple indications; serve as the global regulatory single point-of-contact, leading the Global Regulatory Team; coordinate interactions with regulatory agencies such as the FDA, review and approve clinical and registration documents, and support lifecycle management and regulatory compliance. Requirements: B.S. or higher in biological sciences with 7–10+ years in drug development, primarily in regulatory affairs; strong leadership, communication, and negotiation skills; experience managing complex development programs, including IND/CTA, NDA/BLA submissions, and interactions with global agencies. Preferred: extensive experience in cardiovascular, renal, or respiratory therapeutic areas, including pediatric, orphan, and expedited pathways; familiarity with small and large molecules, devices, and global markets such as EU, China, and Japan; prior oversight of regulatory submissions and approvals. High-value: focus on cardiovascular metabolic products, early to late-stage development, global regulatory strategy, and complex program management. Reporting to an executive leader, with a hybrid work setup and approximately 10% travel.