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

Role: Senior Principal Scientist, Regulatory Affairs Liaison in General Medicine, focusing on cardiovascular metabolic development programs. Objectives: develop and execute global regulatory strategies to optimize labeling and minimize approval timelines across multiple indications and regions. Responsibilities: serve as Global Regulatory Lead, provide strategic regulatory oversight, coordinate interactions with global agencies (FDA, EMA, etc.), lead cross-functional Regulatory Teams, review registration protocols and submissions, and support lifecycle management. Requirements: degree in biological sciences or related field; 10+ years (B.S./M.S.) or 7+ years (PhD/MD/PharmD) in drug development with substantial regulatory affairs experience; demonstrated leadership, negotiation, and communication skills. Preferred: experience in cardiovascular/renal/respiratory therapeutics, global regulatory submissions including IND/CTA and NDA/BLA, knowledge of devices, and familiarity with expedited pathways and pediatric/rare diseases. High-Value: cardiovascular metabolic focus, global oversight, complex multi-indication programs, regulatory agency engagement, and programs in early to late-stage development. Work setup: hybrid, with 10% travel.