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

Senior Principal Scientist position leading global regulatory strategy for cardiovascular-metabolic programs at Merck's General Medicine division. The role involves managing complex development programs across multiple indications, serving as the primary regulatory contact with health authorities, and overseeing cross-functional teams to optimize labeling and expedite approvals.

Responsibilities

• Develop and execute global regulatory strategy for cardiovascular-metabolic programs to optimize labeling and achieve shortest time to approval
• Serve as Global Regulatory Lead and single point of contact for assigned programs with FDA and global regulatory agencies
• Lead Global Regulatory Teams providing cross-functional coordination for development and marketed products throughout drug lifecycle
• Review and approve regulatory submissions including protocols, marketing applications, and clinical study reports before external release
• Represent company in FDA interactions including chairing meetings and preparing teams for regulatory discussions at all development phases

Requirements

• B.S. in biological science with 10+ years drug development experience, majority in regulatory affairs
• M.S. in biological science with 10+ years drug development experience, majority in regulatory affairs
• M.D. with 7+ years drug development experience and 5+ years in regulatory affairs
• Ph.D. or PharmD with 7+ years drug development experience and 5+ years in regulatory affairs
• Outstanding written and verbal communication with demonstrated leadership and team-building experience
• Ability to work independently with minimal oversight and navigate complex regulatory challenges