Principal Scientist, Regulatory Liaison
Merck
August 22, 2026
Remote friendly (North Wales, PA)
United States
Corporate Functions
Responsibilities:
- Provide regulatory oversight as the single, accountable global point of contact for assigned projects within Global Regulatory Affairs and Clinical Safety and externally.
- Develop worldwide regulatory strategy to optimize labeling and shorten time to approval for multiple indications simultaneously.
- Advise product development teams and subsidiaries on regulatory issues across the product life cycle.
- Lead the Global Regulatory Team and coordinate cross-functional regulatory support.
- Communicate with FDA (calls, email), chair FDA meetings, and prepare internal teams for FDA meetings.
- Lead advisory committee preparation and may present at advisory committees.
- Coordinate interactions with foreign agencies (Regulatory Affairs Europe and subsidiary registration) and provide strategic direction across regions.
- Review and provide final approval for Worldwide Marketing Applications, Clinical Study Reports, Protocols, and Investigators Brochures before external release.
- Represent GR in internal committees and provide regulatory advice/approvals.
- Conduct initial IND/Clinical Study Agreement content review and approval.
- Support regulatory due diligence for licensing and work with business development on regulatory responsibilities.
Education (minimum):
- M.D. or Ph.D. (or related doctoral degree). Or M.S. with substantial regulatory affairs experience.
Required experience/skills:
- M.D.: 3+ years; Ph.D.: 5+ years; M.S.: 7+ years drug development/clinical experience (preference in regulatory affairs).
- Excellent oral/written communication; strong organization; flexibility; strong scientific/analytical skills; ability to achieve optimal results with limited day-to-day direction.
Preferred:
- Substantial regulatory affairs experience; vaccines/infectious diseases therapeutic experience (antibacterial/antifungal/antiviral).
Benefits (if applicable as listed):
- Annual bonus and long-term incentive (if applicable); medical, dental, vision, insurance, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting; job posting end date 08/13/2026. Requisition ID: R408715.
- Provide regulatory oversight as the single, accountable global point of contact for assigned projects within Global Regulatory Affairs and Clinical Safety and externally.
- Develop worldwide regulatory strategy to optimize labeling and shorten time to approval for multiple indications simultaneously.
- Advise product development teams and subsidiaries on regulatory issues across the product life cycle.
- Lead the Global Regulatory Team and coordinate cross-functional regulatory support.
- Communicate with FDA (calls, email), chair FDA meetings, and prepare internal teams for FDA meetings.
- Lead advisory committee preparation and may present at advisory committees.
- Coordinate interactions with foreign agencies (Regulatory Affairs Europe and subsidiary registration) and provide strategic direction across regions.
- Review and provide final approval for Worldwide Marketing Applications, Clinical Study Reports, Protocols, and Investigators Brochures before external release.
- Represent GR in internal committees and provide regulatory advice/approvals.
- Conduct initial IND/Clinical Study Agreement content review and approval.
- Support regulatory due diligence for licensing and work with business development on regulatory responsibilities.
Education (minimum):
- M.D. or Ph.D. (or related doctoral degree). Or M.S. with substantial regulatory affairs experience.
Required experience/skills:
- M.D.: 3+ years; Ph.D.: 5+ years; M.S.: 7+ years drug development/clinical experience (preference in regulatory affairs).
- Excellent oral/written communication; strong organization; flexibility; strong scientific/analytical skills; ability to achieve optimal results with limited day-to-day direction.
Preferred:
- Substantial regulatory affairs experience; vaccines/infectious diseases therapeutic experience (antibacterial/antifungal/antiviral).
Benefits (if applicable as listed):
- Annual bonus and long-term incentive (if applicable); medical, dental, vision, insurance, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting; job posting end date 08/13/2026. Requisition ID: R408715.