Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases
Merck
June 30, 2026
Remote friendly (Boston, MA)
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 independent regulatory oversight; 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 drug life cycle.
- Lead the Global Regulatory Team and coordinate cross-functional regulatory support.
- Represent the company with external organizations (e.g., FDA communication, chair meetings, prepare teams for meetings).
- Lead advisory committee preparation and may speak at advisory committees.
- Coordinate interactions with foreign agencies to support multi-region strategy.
- Review and provide final approval of Worldwide Marketing Applications, Clinical Study Reports, Protocols, and Investigators Brochures.
- Provide regulatory advice/approval within internal committees (e.g., Document Review, Product Development, Early Development, Label Evaluation).
- Review and approve initial IND/Clinical Study Agreement content to facilitate regulatory approval for clinical trials.
- Participate in regulatory due diligence and support business development licensing/regulatory responsibilities.
Required Qualifications:
- M.D. or Ph.D. or other related doctoral degree; or master’s with substantial regulatory affairs experience.
- 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/written communication; strong organization; flexibility; strong scientific/analytical skills with attention to detail.
- Ability to perform with limited day-to-day direction.
Preferred Qualifications:
- Substantial regulatory affairs experience.
- Vaccine/infectious disease therapeutic area experience; experience with antibacterial/antifungal/antiviral agents.
Required Skills (selected):
- Pharmaceutical Regulatory Affairs, Regulatory Strategy Development, Regulatory Writing, Regulatory Affairs Compliance, Regulatory Intelligence, Pharmacovigilance, Clinical Trial Planning, Medical Writing, Cross-Functional Collaboration, Leadership.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). 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 independent regulatory oversight; 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 drug life cycle.
- Lead the Global Regulatory Team and coordinate cross-functional regulatory support.
- Represent the company with external organizations (e.g., FDA communication, chair meetings, prepare teams for meetings).
- Lead advisory committee preparation and may speak at advisory committees.
- Coordinate interactions with foreign agencies to support multi-region strategy.
- Review and provide final approval of Worldwide Marketing Applications, Clinical Study Reports, Protocols, and Investigators Brochures.
- Provide regulatory advice/approval within internal committees (e.g., Document Review, Product Development, Early Development, Label Evaluation).
- Review and approve initial IND/Clinical Study Agreement content to facilitate regulatory approval for clinical trials.
- Participate in regulatory due diligence and support business development licensing/regulatory responsibilities.
Required Qualifications:
- M.D. or Ph.D. or other related doctoral degree; or master’s with substantial regulatory affairs experience.
- 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/written communication; strong organization; flexibility; strong scientific/analytical skills with attention to detail.
- Ability to perform with limited day-to-day direction.
Preferred Qualifications:
- Substantial regulatory affairs experience.
- Vaccine/infectious disease therapeutic area experience; experience with antibacterial/antifungal/antiviral agents.
Required Skills (selected):
- Pharmaceutical Regulatory Affairs, Regulatory Strategy Development, Regulatory Writing, Regulatory Affairs Compliance, Regulatory Intelligence, Pharmacovigilance, Clinical Trial Planning, Medical Writing, Cross-Functional Collaboration, Leadership.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.