Sr. Principal Scientist (Sr. Director) - Regulatory Liaison
Merck
August 13, 2026
Remote friendly (Rockville, MD)
United States
Corporate Functions
Primary Activities (not limited to):
- Oversee development and execution of worldwide regulatory strategy for cardiovascular/ metabolic programs to optimize labeling and achieve shortest time to approval for multiple indications.
- Serve as Global Regulatory Lead (GRL) and single global point of contact; provide regulatory single-point-of-contact and expert advice across EDT/PDT and GRACS throughout the product life cycle.
- Lead the Global Regulatory Team (GRT) for assigned cardiovascular/renal/respiratory programs; coordinate global cross-functional regulatory support.
- Review and approve local registration study protocols for marketing authorization in secondary markets.
- Communicate with external organizations (including FDA): calls/emails, chair meetings, prepare internal teams for FDA meetings.
- Coordinate interactions with global regulatory agencies across multiple regions.
- Review and approve Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures before release.
- Provide regulatory advice/approval within internal committees (e.g., label development, PDT/EDT, Document Review Committees).
- Conduct initial IND/CSA content review and approval.
- Participate in regulatory due diligence for licensing candidate review.
Minimum Education/Experience:
- Degree in biological science or related discipline.
- B.S./M.S.: 10+ years relevant drug development experience (majority in regulatory affairs).
- M.D.: 7+ years (5 in regulatory affairs).
- PhD/PharmD: 7+ years (5 in regulatory affairs).
Required:
- Ability to achieve optimal results with limited day-to-day direction.
- Outstanding interpersonal, verbal/written communication, and negotiation skills.
- Demonstrated leadership; experience building and leading high-performing teams.
Preferred:
- Cardiovascular/renal/respiratory experience (incl. pediatrics, orphan, expedited).
- Small/large molecule experience; global markets (EU/China/Japan).
- Prior GRL oversight (IND/CTAs; NDA/BLAs).
- Device knowledge; proficiency in AI tools.
Required Skills: Biological Sciences; Drug Development; Global Health; Pharmaceutical Regulatory Affairs; Regulatory Strategy Development; Regulatory Compliance/Issues/Communications/Management; Product Approvals; Process Improvements; Written Communication; (incl. Clinical Reporting and IVD).
Benefits (explicit): annual bonus and long-term incentive (if applicable); medical/dental/vision, 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.
- Oversee development and execution of worldwide regulatory strategy for cardiovascular/ metabolic programs to optimize labeling and achieve shortest time to approval for multiple indications.
- Serve as Global Regulatory Lead (GRL) and single global point of contact; provide regulatory single-point-of-contact and expert advice across EDT/PDT and GRACS throughout the product life cycle.
- Lead the Global Regulatory Team (GRT) for assigned cardiovascular/renal/respiratory programs; coordinate global cross-functional regulatory support.
- Review and approve local registration study protocols for marketing authorization in secondary markets.
- Communicate with external organizations (including FDA): calls/emails, chair meetings, prepare internal teams for FDA meetings.
- Coordinate interactions with global regulatory agencies across multiple regions.
- Review and approve Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures before release.
- Provide regulatory advice/approval within internal committees (e.g., label development, PDT/EDT, Document Review Committees).
- Conduct initial IND/CSA content review and approval.
- Participate in regulatory due diligence for licensing candidate review.
Minimum Education/Experience:
- Degree in biological science or related discipline.
- B.S./M.S.: 10+ years relevant drug development experience (majority in regulatory affairs).
- M.D.: 7+ years (5 in regulatory affairs).
- PhD/PharmD: 7+ years (5 in regulatory affairs).
Required:
- Ability to achieve optimal results with limited day-to-day direction.
- Outstanding interpersonal, verbal/written communication, and negotiation skills.
- Demonstrated leadership; experience building and leading high-performing teams.
Preferred:
- Cardiovascular/renal/respiratory experience (incl. pediatrics, orphan, expedited).
- Small/large molecule experience; global markets (EU/China/Japan).
- Prior GRL oversight (IND/CTAs; NDA/BLAs).
- Device knowledge; proficiency in AI tools.
Required Skills: Biological Sciences; Drug Development; Global Health; Pharmaceutical Regulatory Affairs; Regulatory Strategy Development; Regulatory Compliance/Issues/Communications/Management; Product Approvals; Process Improvements; Written Communication; (incl. Clinical Reporting and IVD).
Benefits (explicit): annual bonus and long-term incentive (if applicable); medical/dental/vision, 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.