Principal Scientist, Regulatory Liaison
Merck
August 22, 2026
Remote friendly (Rahway, NJ)
United States
Corporate Functions
Role: Regulatory Affairs Headquarters Principal Scientist (Vaccines & Infectious Disease)
Primary responsibilities:
- Provide regulatory oversight for assigned products as the single global regulatory point of contact (GRACS and external to GRACS).
- Develop worldwide regulatory strategy to optimize labels and shortest time to approval across 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.
- Communicate directly with FDA (calls/email), chair FDA meetings, and prepare teams for FDA meetings.
- Lead/adapt cross-functional preparation for advisory committees; may speak at committees.
- Coordinate interactions with foreign agencies via Regulatory Affairs Europe and subsidiaries; provide multi-region strategic direction.
- Review and provide final approval for Worldwide Marketing Applications, Clinical Study Reports, Protocols, and Investigators Brochures before external release.
- Represent GR on internal committees and conduct initial IND/Clinical Study Agreement content review/approval.
- Participate in regulatory due diligence for licensing candidates and support business development regulatory responsibilities.
Education (minimum):
- M.D. or Ph.D. or related doctoral degree; or master’s with substantial regulatory affairs experience.
Required experience/skills:
- M.D.: 3+ years drug development/clinical; OR Ph.D.: 5+ years; OR M.S.: 7+ years (preference regulatory affairs).
- Excellent oral/written communication; strong organization; flexibility; scientific/analytical skills; independent results with limited day-to-day direction.
Preferred:
- Substantial regulatory affairs experience; vaccines/infectious disease experience (antibacterial/antifungal/antiviral).
Benefits (as stated):
- Comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and sick/compassionate days.
Application:
- Apply via https://jobs.merck.com/us/en (deadline stated on posting). Requisition ID: R408715.
Primary responsibilities:
- Provide regulatory oversight for assigned products as the single global regulatory point of contact (GRACS and external to GRACS).
- Develop worldwide regulatory strategy to optimize labels and shortest time to approval across 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.
- Communicate directly with FDA (calls/email), chair FDA meetings, and prepare teams for FDA meetings.
- Lead/adapt cross-functional preparation for advisory committees; may speak at committees.
- Coordinate interactions with foreign agencies via Regulatory Affairs Europe and subsidiaries; provide multi-region strategic direction.
- Review and provide final approval for Worldwide Marketing Applications, Clinical Study Reports, Protocols, and Investigators Brochures before external release.
- Represent GR on internal committees and conduct initial IND/Clinical Study Agreement content review/approval.
- Participate in regulatory due diligence for licensing candidates and support business development regulatory responsibilities.
Education (minimum):
- M.D. or Ph.D. or related doctoral degree; or master’s with substantial regulatory affairs experience.
Required experience/skills:
- M.D.: 3+ years drug development/clinical; OR Ph.D.: 5+ years; OR M.S.: 7+ years (preference regulatory affairs).
- Excellent oral/written communication; strong organization; flexibility; scientific/analytical skills; independent results with limited day-to-day direction.
Preferred:
- Substantial regulatory affairs experience; vaccines/infectious disease experience (antibacterial/antifungal/antiviral).
Benefits (as stated):
- Comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and sick/compassionate days.
Application:
- Apply via https://jobs.merck.com/us/en (deadline stated on posting). Requisition ID: R408715.