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

Role: Senior Principal Scientist, Regulatory Affairs Liaison, leading global regulatory strategies for cardiovascular/metabolic development programs. Responsibilities: develop and execute regulatory plans to optimize labeling and approval timelines for multiple indications, serve as the global regulatory single point-of-contact, lead cross-functional regulatory teams, review and approve study protocols and submissions, liaise with global agencies including FDA, and support regulatory due diligence. Requirements: B.S. with 10+ years or M.S./PhD/MD with 7+ years in drug regulatory affairs, with substantial experience in cardiovascular/renal/respiratory areas, including both small and large molecules. Preferred: experience with pediatric, orphan, expedited development, global markets (EU, China, Japan), and device knowledge. Skills: regulatory strategy development, global health agency interaction, drug development, clinical and regulatory documentation, compliance. High-value: focus on cardiovascular/metabolic therapeutic areas, complex multi-indication programs, early to late development phases, global regulatory interactions, and cross-functional leadership. Work setup: hybrid with ~10% travel.