Sr. Principal Scientist (Sr. Director) - Regulatory Liaison
Merck
August 20, 2026
Remote friendly (Rahway, NJ)
United States
Corporate Functions
Senior Principal Scientist, Regulatory Affairs Liaison
Primary Activities Include, But Are Not Limited To
- Oversee worldwide regulatory strategy development and execution for assigned cardiovascular metabolic programs to optimize labeling and achieve shortest time to approval across multiple indications.
- Serve as Global Regulatory Lead (GRL): regulatory single, accountable global point of contact interacting with global regulators and/or subsidiaries for global regulatory strategy/registration requirements for investigational and marketed drugs/biologics.
- Provide expert regulatory advice to Early Development and Product Development teams (EDT/PDT) and act as regulatory single point-of-contact for issues across the full product lifecycle.
- Lead the Global Regulatory Team (GRT) coordinating global, cross-functional regulatory support for assigned cardiovascular/renal/respiratory programs.
- Review and provide final approval of local registration study protocols for secondary market marketing authorization.
- Represent the company with FDA (calls/emails), chair company–FDA meetings, and prepare teams for FDA meetings.
- Coordinate interactions with global regulatory agencies via regional/subsidiary registration groups to provide strategic direction across regions.
- Review and provide final approval of Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures before external release.
- Provide regulatory advice/approval within internal committees per charters.
- Conduct initial IND/CSA content review and approval to facilitate agency approval for clinical trials.
- Participate in regulatory due diligence for licensing candidate review.
Minimum Education & Experience Requirements
- Degree in biological science or related discipline.
- B.S. (10+ years drug development; majority in regulatory affairs)
- M.S. (10+ years; majority in regulatory affairs)
- M.D. (7+ years; 5+ in regulatory affairs)
- PhD/PharmD (7+ years; 5+ in regulatory affairs)
Required
- Ability to achieve optimal results with limited day-to-day direction.
- Outstanding interpersonal, verbal/written communication, and negotiation skills.
- Demonstrated leadership (building and leading high-performing teams).
Preferred Experience
- Cardiovascular/renal/respiratory program experience, including pediatrics, orphan drug, expedited development.
- Small and large molecule development experience.
- Global regulatory experience (EU, China, Japan).
- Prior GRL oversight of IND/CTAs and NDA/BLAs.
- Device knowledge (e.g., inhalers, auto injectors, pre-filled syringes).
- Proficiency in AI applications (e.g., Copilot, ChatGPT).
Required Skills
- Biological Sciences; Clinical Reporting; Drug Development; Global Health; In Vitro Diagnostics (IVD); Pharmaceutical Regulatory Affairs; Regulatory Compliance/Management/Issues/Strategies/Strategy Development/Communications; Process Improvements; Product Approvals; Written Communication.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee).
Primary Activities Include, But Are Not Limited To
- Oversee worldwide regulatory strategy development and execution for assigned cardiovascular metabolic programs to optimize labeling and achieve shortest time to approval across multiple indications.
- Serve as Global Regulatory Lead (GRL): regulatory single, accountable global point of contact interacting with global regulators and/or subsidiaries for global regulatory strategy/registration requirements for investigational and marketed drugs/biologics.
- Provide expert regulatory advice to Early Development and Product Development teams (EDT/PDT) and act as regulatory single point-of-contact for issues across the full product lifecycle.
- Lead the Global Regulatory Team (GRT) coordinating global, cross-functional regulatory support for assigned cardiovascular/renal/respiratory programs.
- Review and provide final approval of local registration study protocols for secondary market marketing authorization.
- Represent the company with FDA (calls/emails), chair company–FDA meetings, and prepare teams for FDA meetings.
- Coordinate interactions with global regulatory agencies via regional/subsidiary registration groups to provide strategic direction across regions.
- Review and provide final approval of Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures before external release.
- Provide regulatory advice/approval within internal committees per charters.
- Conduct initial IND/CSA content review and approval to facilitate agency approval for clinical trials.
- Participate in regulatory due diligence for licensing candidate review.
Minimum Education & Experience Requirements
- Degree in biological science or related discipline.
- B.S. (10+ years drug development; majority in regulatory affairs)
- M.S. (10+ years; majority in regulatory affairs)
- M.D. (7+ years; 5+ in regulatory affairs)
- PhD/PharmD (7+ years; 5+ in regulatory affairs)
Required
- Ability to achieve optimal results with limited day-to-day direction.
- Outstanding interpersonal, verbal/written communication, and negotiation skills.
- Demonstrated leadership (building and leading high-performing teams).
Preferred Experience
- Cardiovascular/renal/respiratory program experience, including pediatrics, orphan drug, expedited development.
- Small and large molecule development experience.
- Global regulatory experience (EU, China, Japan).
- Prior GRL oversight of IND/CTAs and NDA/BLAs.
- Device knowledge (e.g., inhalers, auto injectors, pre-filled syringes).
- Proficiency in AI applications (e.g., Copilot, ChatGPT).
Required Skills
- Biological Sciences; Clinical Reporting; Drug Development; Global Health; In Vitro Diagnostics (IVD); Pharmaceutical Regulatory Affairs; Regulatory Compliance/Management/Issues/Strategies/Strategy Development/Communications; Process Improvements; Product Approvals; Written Communication.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee).