Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases
Merck
June 30, 2026
Remote friendly (Rahway, NJ)
United States
Corporate Functions
Brief Description of Position
- Develop and implement global regulatory strategy for assigned Vaccines and Infectious Disease projects.
Primary Activities
- Provide independent regulatory oversight and serve as the single, accountable global regulatory point of contact.
- Develop worldwide product regulatory strategy to optimize labeling and shorten time to approval for multiple indications.
- Advise Product Development Teams and subsidiaries across the full product life cycle.
- Lead the Global Regulatory Team; coordinate cross-functional regulatory support.
- Communicate with the FDA (calls/e-mail), chair FDA meetings, and prepare internal teams for FDA meetings.
- Lead preparations for advisory committees; may speak at advisory committees.
- Coordinate foreign agency interactions (Regulatory Affairs Europe and subsidiary registration teams) and provide multi-region strategic direction.
- Review and provide final approval of Worldwide Marketing Applications, Clinical Study Reports, Protocols, and Investigators Brochures.
- Represent GR on internal committees for regulatory advice/approvals.
- Conduct initial IND/Clinical Study Agreement content review and approval.
- Participate in regulatory due diligence and support licensing and business development regulatory responsibilities.
Qualifications
- Education: M.D. or Ph.D. (or related doctoral degree); or M.S. with substantial regulatory affairs experience.
- Experience: M.D. (3+ years) or Ph.D. (5+ years) or M.S. (7+ years) in relevant drug development/clinical experience; regulatory affairs preferred.
Skills (Required/Preferred)
- Excellent oral/written communication; strong organizational, analytical, scientific/attention to detail; flexibility; ability to perform with limited day-to-day direction.
- Preferred: substantial regulatory affairs experience; vaccines/infectious disease experience (antibacterial/antifungal/antiviral).
Salary/Benefits & Application
- Annual bonus and long-term incentive (if applicable); comprehensive benefits include medical/dental/vision, retirement/401(k), paid holidays, vacation, and sick/compassionate days.
- Apply via https://jobs.merck.com/us/en. (Application deadline per posting.)
- Develop and implement global regulatory strategy for assigned Vaccines and Infectious Disease projects.
Primary Activities
- Provide independent regulatory oversight and serve as the single, accountable global regulatory point of contact.
- Develop worldwide product regulatory strategy to optimize labeling and shorten time to approval for multiple indications.
- Advise Product Development Teams and subsidiaries across the full product life cycle.
- Lead the Global Regulatory Team; coordinate cross-functional regulatory support.
- Communicate with the FDA (calls/e-mail), chair FDA meetings, and prepare internal teams for FDA meetings.
- Lead preparations for advisory committees; may speak at advisory committees.
- Coordinate foreign agency interactions (Regulatory Affairs Europe and subsidiary registration teams) and provide multi-region strategic direction.
- Review and provide final approval of Worldwide Marketing Applications, Clinical Study Reports, Protocols, and Investigators Brochures.
- Represent GR on internal committees for regulatory advice/approvals.
- Conduct initial IND/Clinical Study Agreement content review and approval.
- Participate in regulatory due diligence and support licensing and business development regulatory responsibilities.
Qualifications
- Education: M.D. or Ph.D. (or related doctoral degree); or M.S. with substantial regulatory affairs experience.
- Experience: M.D. (3+ years) or Ph.D. (5+ years) or M.S. (7+ years) in relevant drug development/clinical experience; regulatory affairs preferred.
Skills (Required/Preferred)
- Excellent oral/written communication; strong organizational, analytical, scientific/attention to detail; flexibility; ability to perform with limited day-to-day direction.
- Preferred: substantial regulatory affairs experience; vaccines/infectious disease experience (antibacterial/antifungal/antiviral).
Salary/Benefits & Application
- Annual bonus and long-term incentive (if applicable); comprehensive benefits include medical/dental/vision, retirement/401(k), paid holidays, vacation, and sick/compassionate days.
- Apply via https://jobs.merck.com/us/en. (Application deadline per posting.)