Sr. Principal Scientist (Sr. Director) - Regulatory Liaison
Merck
July 01, 2026
Remote friendly (Boston, MA)
United States
Corporate Functions
Senior Principal Scientist, Regulatory Affairs Liaison (General Medicine)
Primary Activities
- Oversee worldwide regulatory strategy development and execution for cardiovascular metabolic programs to optimize labeling and achieve shortest time to approval.
- Serve as Global Regulatory Lead (GRL): global single point of contact for regulatory strategy/registration requirements with agencies and subsidiaries for investigational and marketed drugs/biologics across early/late-stage development.
- Provide expert regulatory advice to Early Development/Product Development teams and act as point-of-contact across Global Regulatory Affairs and Clinical Safety.
- Lead the Global Regulatory Team coordinating cross-functional regulatory support for development and marketed products.
- Review/approve local registration study protocols for secondary-market marketing authorization.
- Communicate with FDA (calls/emails), chair meetings, and prepare teams for FDA meetings.
- Coordinate agency interactions across regions (Europe/International/subsidiary registration departments).
- Review/approve Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures before external release.
- Conduct initial IND/CSA content review/approval; participate in regulatory due diligence for licensing candidates.
Minimum Education & Experience
- Degree in biological science or related discipline.
- B.S./M.S. with 10+ years relevant drug development experience (majority in regulatory affairs).
- M.D. with 7+ years (5+ in regulatory affairs). PhD/PharmD with 7+ years (5+ in regulatory affairs).
Required
- Ability to achieve optimal results with limited day-to-day direction.
- Strong interpersonal, verbal/written communication, and negotiation.
- Demonstrated leadership (building/leading high-performing teams).
Preferred
- Cardiovascular/renal/respiratory experience (incl. pediatrics, orphan, expedited development).
- Global regulatory experience (EU/China/Japan); prior GRL oversight (IND/CTAs, NDA/BLAs).
- Small/large molecule experience; device knowledge; AI application proficiency.
Benefits & Incentives (if applicable)
- Eligible for annual bonus and long-term incentive.
- Comprehensive benefits package (medical/dental/vision, retirement/401(k), paid holidays/vacation, and sick/compassionate days).
Application
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.
Primary Activities
- Oversee worldwide regulatory strategy development and execution for cardiovascular metabolic programs to optimize labeling and achieve shortest time to approval.
- Serve as Global Regulatory Lead (GRL): global single point of contact for regulatory strategy/registration requirements with agencies and subsidiaries for investigational and marketed drugs/biologics across early/late-stage development.
- Provide expert regulatory advice to Early Development/Product Development teams and act as point-of-contact across Global Regulatory Affairs and Clinical Safety.
- Lead the Global Regulatory Team coordinating cross-functional regulatory support for development and marketed products.
- Review/approve local registration study protocols for secondary-market marketing authorization.
- Communicate with FDA (calls/emails), chair meetings, and prepare teams for FDA meetings.
- Coordinate agency interactions across regions (Europe/International/subsidiary registration departments).
- Review/approve Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures before external release.
- Conduct initial IND/CSA content review/approval; participate in regulatory due diligence for licensing candidates.
Minimum Education & Experience
- Degree in biological science or related discipline.
- B.S./M.S. with 10+ years relevant drug development experience (majority in regulatory affairs).
- M.D. with 7+ years (5+ in regulatory affairs). PhD/PharmD with 7+ years (5+ in regulatory affairs).
Required
- Ability to achieve optimal results with limited day-to-day direction.
- Strong interpersonal, verbal/written communication, and negotiation.
- Demonstrated leadership (building/leading high-performing teams).
Preferred
- Cardiovascular/renal/respiratory experience (incl. pediatrics, orphan, expedited development).
- Global regulatory experience (EU/China/Japan); prior GRL oversight (IND/CTAs, NDA/BLAs).
- Small/large molecule experience; device knowledge; AI application proficiency.
Benefits & Incentives (if applicable)
- Eligible for annual bonus and long-term incentive.
- Comprehensive benefits package (medical/dental/vision, retirement/401(k), paid holidays/vacation, and sick/compassionate days).
Application
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.