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

Role: Senior Principal Scientist, Regulatory Affairs Liaison, leading global regulatory strategy for cardiovascular/metabolic programs in General Medicine. Responsibilities: independently manage and develop strategies to optimize labeling and achieve rapid approval; serve as global regulatory lead, interact with authorities including FDA, review and approve submissions, protocols, and reports; lead cross-functional regulatory teams and support development in early and late phases; participate in regulatory due diligence and represent the company externally. Requirements: degree in biological sciences or related field; 10+ years in drug development with substantial regulatory affairs experience; strong leadership, communication, and negotiation skills. Preferred: experience with cardiovascular/renal/respiratory modalities, pediatrics, orphan drugs, expedited pathways; global regulatory experience, including IND/CTA and NDA/BLA submissions; familiarity with devices and AI tools. HighValue: cardiovascular metabolic therapies, global regulatory strategy, early to late-stage development, complex multi-indication programs, FDA interactions, cross-regional submissions. WorkSetup: hybrid in the US, with 10% travel.