Sr. Principal Scientist (Sr. Director) - Regulatory Liaison
Merck · Rahway, NJ +3 more
RegulatoryFull-time$191k–$300kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
This role links to Merck's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.