Sr. Principal Scientist (Sr. Director) - Regulatory Liaison
Merck
July 01, 2026
Remote friendly (Rahway, NJ)
United States
Corporate Functions
Senior Principal Scientist, Regulatory Affairs Liaison
Primary Activities (Responsibilities):
- Oversee the development and execution of worldwide regulatory strategy for cardiovascular metabolic programs to optimize labeling and achieve shortest time to approval for multiple indications simultaneously.
- Serve as Global Regulatory Lead (GRL): single, accountable global point of contact for regulatory strategy/registration requirements; interact with global regulators and/or subsidiaries for one or more company investigational/marketed drugs/biologics.
- Provide expert regulatory advice as GRL to Early Development/Product Development teams and regulatory single point-of-contact across the product life cycle.
- Lead the Global Regulatory Team (GRT) coordinating global, cross-functional regulatory support for cardiovascular/renal/respiratory programs.
- Review and provide final approval of local registration study protocols for secondary markets.
- Liaise with FDA (calls/emails), chair FDA meetings, and prepare internal teams for FDA interactions at any development phase.
- Coordinate interactions with global regulatory agencies via regional/regional subsidiary registration groups to support multiple regions.
- Review and provide final approval of Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures prior to external release.
- Represent Global Regulatory Affairs on internal committees (e.g., therapeutic area Document Review Committees, PDT/EDT, label development).
- Conduct initial IND/CSA content review and approval; participate in regulatory due diligence for licensing candidate review.
Minimum Education & Experience:
- Degree in biological science or related discipline.
- BS or MS: 10+ years relevant drug development experience (majority in regulatory affairs).
- MD: 7+ years relevant experience with 5+ in regulatory affairs.
- PhD/PharmD: 7+ years relevant experience with 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:
- Cardiovascular/renal/respiratory experience (including pediatrics, orphan drug, expedited development).
- Small and large molecule experience.
- Global regulatory experience (EU, China, Japan).
- Prior GRL oversight (IND/CTAs, NDA/BLAs).
- Device knowledge (e.g., inhalers, auto-injectors, pre-filled syringes).
- Proficient with AI applications (e.g., Co-pilot, ChatGPT).
Required Skills:
- Biological Sciences; Clinical Reporting; Drug Development; Global Health; In Vitro Diagnostics (IVD); Multiple Therapeutic Areas; Pharmaceutical Regulatory Affairs; Process Improvements; Product Approvals; Regulatory Affairs Compliance/Management/Communications; Regulatory Compliance/Issues/Strategies/Strategy Development; Written Communication.
Application Instructions:
- Apply at https://jobs.merck.com/us/en (or via Workday Jobs Hub if a current employee). Application deadline is stated on the posting.
Primary Activities (Responsibilities):
- Oversee the development and execution of worldwide regulatory strategy for cardiovascular metabolic programs to optimize labeling and achieve shortest time to approval for multiple indications simultaneously.
- Serve as Global Regulatory Lead (GRL): single, accountable global point of contact for regulatory strategy/registration requirements; interact with global regulators and/or subsidiaries for one or more company investigational/marketed drugs/biologics.
- Provide expert regulatory advice as GRL to Early Development/Product Development teams and regulatory single point-of-contact across the product life cycle.
- Lead the Global Regulatory Team (GRT) coordinating global, cross-functional regulatory support for cardiovascular/renal/respiratory programs.
- Review and provide final approval of local registration study protocols for secondary markets.
- Liaise with FDA (calls/emails), chair FDA meetings, and prepare internal teams for FDA interactions at any development phase.
- Coordinate interactions with global regulatory agencies via regional/regional subsidiary registration groups to support multiple regions.
- Review and provide final approval of Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures prior to external release.
- Represent Global Regulatory Affairs on internal committees (e.g., therapeutic area Document Review Committees, PDT/EDT, label development).
- Conduct initial IND/CSA content review and approval; participate in regulatory due diligence for licensing candidate review.
Minimum Education & Experience:
- Degree in biological science or related discipline.
- BS or MS: 10+ years relevant drug development experience (majority in regulatory affairs).
- MD: 7+ years relevant experience with 5+ in regulatory affairs.
- PhD/PharmD: 7+ years relevant experience with 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:
- Cardiovascular/renal/respiratory experience (including pediatrics, orphan drug, expedited development).
- Small and large molecule experience.
- Global regulatory experience (EU, China, Japan).
- Prior GRL oversight (IND/CTAs, NDA/BLAs).
- Device knowledge (e.g., inhalers, auto-injectors, pre-filled syringes).
- Proficient with AI applications (e.g., Co-pilot, ChatGPT).
Required Skills:
- Biological Sciences; Clinical Reporting; Drug Development; Global Health; In Vitro Diagnostics (IVD); Multiple Therapeutic Areas; Pharmaceutical Regulatory Affairs; Process Improvements; Product Approvals; Regulatory Affairs Compliance/Management/Communications; Regulatory Compliance/Issues/Strategies/Strategy Development; Written Communication.
Application Instructions:
- Apply at https://jobs.merck.com/us/en (or via Workday Jobs Hub if a current employee). Application deadline is stated on the posting.