Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases
Merck
June 30, 2026
Remote friendly (North Wales, PA)
United States
Corporate Functions
Brief Description of Position:
- The Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy for assigned projects in Vaccines and Infectious Disease.
Primary Activities:
- Provide independent regulatory oversight and act as single accountable global regulatory point of contact for assigned projects.
- Develop worldwide regulatory strategy to optimize label and shorten time to approval for multiple indications.
- Advise Product Development Teams and subsidiaries on regulatory issues across the product life cycle.
- Lead Global Regulatory Team; coordinate cross-functional regulatory support for development and marketed products.
- Represent the company with the FDA (calls/emails), chair FDA meetings, and prepare teams for FDA interactions.
- Lead/prepare for advisory committees; may speak at advisory committee.
- Coordinate interactions with foreign agencies (Regulatory Affairs Europe and subsidiary registration) to provide multi-region strategic direction.
- Review and provide final approval for Worldwide Marketing Applications, Clinical Study Reports, Protocols, and Investigators Brochures before external release.
- Provide regulatory advice/approval within internal committees (Document Review, Product Development, Early Development, Label Evaluation).
- Review and approve initial IND/Clinical Study Agreement content to facilitate regulatory approvals.
- Participate in regulatory due diligence for licensing and support business development regulatory responsibilities.
Qualifications:
- Education: M.D. or Ph.D. or related doctoral degree; or master’s with substantial regulatory affairs experience.
- Required experience: M.D. (3+ years) or Ph.D. (5+ years) or M.S. (7+ years), preferably in regulatory affairs.
- Skills: excellent oral/written communication; strong organization; flexibility; strong scientific/analytical skills; ability to deliver with limited direction.
Preferred:
- Substantial regulatory affairs experience; vaccines/infectious disease experience (antibacterial/antifungal/antiviral agents).
Required Skills (examples):
- Medical writing, regulatory strategy development, regulatory intelligence/issues, regulatory writing, regulatory compliance/management, leadership, clinical trial planning.
Travel: 10%.
Application:
- Apply via https://jobs.merck.com/us/en (deadline listed on posting). Requisition ID: R404836.
- The Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy for assigned projects in Vaccines and Infectious Disease.
Primary Activities:
- Provide independent regulatory oversight and act as single accountable global regulatory point of contact for assigned projects.
- Develop worldwide regulatory strategy to optimize label and shorten time to approval for multiple indications.
- Advise Product Development Teams and subsidiaries on regulatory issues across the product life cycle.
- Lead Global Regulatory Team; coordinate cross-functional regulatory support for development and marketed products.
- Represent the company with the FDA (calls/emails), chair FDA meetings, and prepare teams for FDA interactions.
- Lead/prepare for advisory committees; may speak at advisory committee.
- Coordinate interactions with foreign agencies (Regulatory Affairs Europe and subsidiary registration) to provide multi-region strategic direction.
- Review and provide final approval for Worldwide Marketing Applications, Clinical Study Reports, Protocols, and Investigators Brochures before external release.
- Provide regulatory advice/approval within internal committees (Document Review, Product Development, Early Development, Label Evaluation).
- Review and approve initial IND/Clinical Study Agreement content to facilitate regulatory approvals.
- Participate in regulatory due diligence for licensing and support business development regulatory responsibilities.
Qualifications:
- Education: M.D. or Ph.D. or related doctoral degree; or master’s with substantial regulatory affairs experience.
- Required experience: M.D. (3+ years) or Ph.D. (5+ years) or M.S. (7+ years), preferably in regulatory affairs.
- Skills: excellent oral/written communication; strong organization; flexibility; strong scientific/analytical skills; ability to deliver with limited direction.
Preferred:
- Substantial regulatory affairs experience; vaccines/infectious disease experience (antibacterial/antifungal/antiviral agents).
Required Skills (examples):
- Medical writing, regulatory strategy development, regulatory intelligence/issues, regulatory writing, regulatory compliance/management, leadership, clinical trial planning.
Travel: 10%.
Application:
- Apply via https://jobs.merck.com/us/en (deadline listed on posting). Requisition ID: R404836.