Sr. Principal Scientist (Sr. Director) - Regulatory Liaison
Merck
August 13, 2026
Remote friendly (North Wales, PA)
United States
Other
Senior Principal Scientist, Regulatory Affairs Liaison (Regulatory Affairs)
Primary Activities Include, But Are Not Limited To
- Oversee worldwide regulatory strategy development and execution for assigned General Medicine programs (cardiovascular metabolic) to optimize labeling and shortest time to approval across multiple indications.
- Serve as Global Regulatory Lead (GRL): global point of contact for regulatory strategy/registration for one or more investigational/marketed drugs/biologics; interact with global regulatory agencies/subsidiaries.
- Lead Global Regulatory Team coordination for cardiovascular/renal/respiratory programs.
- Provide expert regulatory advice to Early/Product Development and GRACS across the drug lifecycle.
- Review/approve local registration study protocols for secondary markets.
- Communicate directly with FDA (calls/emails), chair meetings, and prepare teams for FDA interactions.
- Coordinate global agency interactions across regions and subsidiary departments.
- Review/approve worldwide marketing applications, clinical study reports, protocols, and investigator brochures before external release.
- Represent Global Regulatory Affairs on internal committees and conduct IND/CSA content reviews/approvals.
- Participate in regulatory due diligence for licensing candidate review.
Minimum Education & Experience
- Degree in biological science or related discipline.
- B.S./M.S.: 10+ years drug development (majority in regulatory affairs); M.D.: 7+ years (5 in regulatory); PhD/PharmD: 7+ years (5 in regulatory).
Required
- Achieve results with limited day-to-day direction; strong verbal/written communication and negotiation; leadership building high-performing teams.
Preferred
- Cardiovascular/renal/respiratory (incl. pediatrics, orphan, expedited); small/large molecules; global markets (EU/China/Japan); prior GRL oversight (IND/CTA, NDA/BLA); device knowledge; AI proficiency.
Required/Preferred Skills (from posting)
- Regulatory strategy development, regulatory communications/compliance, written communication, regulatory issues/management, drug development/product approvals.
Benefits
- Annual bonus and long-term incentive (if applicable); medical/dental/vision, retirement (401(k)), paid holidays/vacation, and sick/compassionate days.
Application
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.
Primary Activities Include, But Are Not Limited To
- Oversee worldwide regulatory strategy development and execution for assigned General Medicine programs (cardiovascular metabolic) to optimize labeling and shortest time to approval across multiple indications.
- Serve as Global Regulatory Lead (GRL): global point of contact for regulatory strategy/registration for one or more investigational/marketed drugs/biologics; interact with global regulatory agencies/subsidiaries.
- Lead Global Regulatory Team coordination for cardiovascular/renal/respiratory programs.
- Provide expert regulatory advice to Early/Product Development and GRACS across the drug lifecycle.
- Review/approve local registration study protocols for secondary markets.
- Communicate directly with FDA (calls/emails), chair meetings, and prepare teams for FDA interactions.
- Coordinate global agency interactions across regions and subsidiary departments.
- Review/approve worldwide marketing applications, clinical study reports, protocols, and investigator brochures before external release.
- Represent Global Regulatory Affairs on internal committees and conduct IND/CSA content reviews/approvals.
- Participate in regulatory due diligence for licensing candidate review.
Minimum Education & Experience
- Degree in biological science or related discipline.
- B.S./M.S.: 10+ years drug development (majority in regulatory affairs); M.D.: 7+ years (5 in regulatory); PhD/PharmD: 7+ years (5 in regulatory).
Required
- Achieve results with limited day-to-day direction; strong verbal/written communication and negotiation; leadership building high-performing teams.
Preferred
- Cardiovascular/renal/respiratory (incl. pediatrics, orphan, expedited); small/large molecules; global markets (EU/China/Japan); prior GRL oversight (IND/CTA, NDA/BLA); device knowledge; AI proficiency.
Required/Preferred Skills (from posting)
- Regulatory strategy development, regulatory communications/compliance, written communication, regulatory issues/management, drug development/product approvals.
Benefits
- Annual bonus and long-term incentive (if applicable); medical/dental/vision, retirement (401(k)), paid holidays/vacation, and sick/compassionate days.
Application
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.