Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases
Merck
June 30, 2026
Remote friendly (Rockville, MD)
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 the Vaccines and Infectious Disease therapeutic area.
Primary Activities Include, But Are Not Limited To
- Provide regulatory oversight for assigned products as the single, accountable global regulatory point of contact.
- Develop worldwide product regulatory strategy to optimize label and shorten time to approval for multiple indications.
- Provide expert regulatory advice to Product Development Teams and subsidiaries across the product life cycle.
- Lead the Global Regulatory Team; coordinate cross-functional regulatory support.
- Represent the company with external organizations (including FDA), chair meetings, and prepare teams for FDA interactions.
- Lead preparations for advisory committees; may speak at advisory committee.
- Coordinate interactions with foreign agencies to provide strategic direction across multiple regions.
- Review and provide final approval for Worldwide Marketing Applications, Clinical Study Reports, Protocols, and Investigators Brochures.
- Represent GR on internal committees and provide regulatory advice/approval.
- Conduct initial IND/Clinical Study Agreement content review and approval.
- Participate in regulatory due diligence and support business development regulatory responsibilities.
Qualifications, Skills & Experience
- Education: M.D. or Ph.D. or related doctoral degree; or a master’s with substantial regulatory affairs experience.
Required Experience and Skills
- M.D.: 3+ years relevant drug development or clinical experience; or Ph.D.: 5+ years; or M.S.: 7+ years (preference for regulatory affairs).
- Excellent oral and written communication; strong organization; flexibility.
- Strong scientific/analytical skills with attention to detail.
- Ability to achieve results with limited day-to-day direction.
Preferred Experience and Skills
- Substantial regulatory affairs experience.
- Vaccine/infectious disease therapeutic area experience (antibacterial/antifungal/antiviral).
Required Skills (examples)
- Regulatory strategy development, regulatory writing/medical writing, leadership, cross-functional collaboration, regulatory intelligence/issues/compliance/management, pharmacovigilance.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.
The Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy for assigned projects in the Vaccines and Infectious Disease therapeutic area.
Primary Activities Include, But Are Not Limited To
- Provide regulatory oversight for assigned products as the single, accountable global regulatory point of contact.
- Develop worldwide product regulatory strategy to optimize label and shorten time to approval for multiple indications.
- Provide expert regulatory advice to Product Development Teams and subsidiaries across the product life cycle.
- Lead the Global Regulatory Team; coordinate cross-functional regulatory support.
- Represent the company with external organizations (including FDA), chair meetings, and prepare teams for FDA interactions.
- Lead preparations for advisory committees; may speak at advisory committee.
- Coordinate interactions with foreign agencies to provide strategic direction across multiple regions.
- Review and provide final approval for Worldwide Marketing Applications, Clinical Study Reports, Protocols, and Investigators Brochures.
- Represent GR on internal committees and provide regulatory advice/approval.
- Conduct initial IND/Clinical Study Agreement content review and approval.
- Participate in regulatory due diligence and support business development regulatory responsibilities.
Qualifications, Skills & Experience
- Education: M.D. or Ph.D. or related doctoral degree; or a master’s with substantial regulatory affairs experience.
Required Experience and Skills
- M.D.: 3+ years relevant drug development or clinical experience; or Ph.D.: 5+ years; or M.S.: 7+ years (preference for regulatory affairs).
- Excellent oral and written communication; strong organization; flexibility.
- Strong scientific/analytical skills with attention to detail.
- Ability to achieve results with limited day-to-day direction.
Preferred Experience and Skills
- Substantial regulatory affairs experience.
- Vaccine/infectious disease therapeutic area experience (antibacterial/antifungal/antiviral).
Required Skills (examples)
- Regulatory strategy development, regulatory writing/medical writing, leadership, cross-functional collaboration, regulatory intelligence/issues/compliance/management, pharmacovigilance.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.