Sr. Principal Scientist (Sr. Director) - Regulatory Liaison
Merck
August 13, 2026
Remote friendly (Boston, MA)
United States
Corporate Functions
Responsibilities:
- Develop and execute worldwide regulatory strategy for General Medicine programs (cardiovascular metabolic) to optimize labeling and obtain shortest time to approval for multiple indications simultaneously.
- Serve as Global Regulatory Lead (GRL): global point of contact for regulatory agencies/subsidiaries; provide strategic regulatory oversight across early- and late-stage development (including complex programs with multiple indications/formulations and external partners).
- Lead Global Regulatory Team (GRT) for assigned cardiovascular/renal/respiratory programs and coordinate global cross-functional regulatory support.
- Provide expert regulatory advice as GRL to Early Development and Product Development Teams within and external to Global Regulatory Affairs and Clinical Safety (GRACS) across the product lifecycle.
- Review and provide final approval of local registration study protocols for secondary markets.
- Communicate directly with FDA (calls/emails), chair meetings, and prepare teams for FDA meetings at any development phase.
- Coordinate with global regulatory agencies via Regulatory Affairs Europe/International and subsidiary registration departments to provide strategic direction across regions.
- Review and provide final approval of Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures before external release.
- Provide regulatory advice/approval in internal committees (e.g., document review, PDT/EDT, label development).
- Conduct initial IND/CSA content review and approval for clinical trial authorizations.
- Participate in regulatory due diligence for licensing candidate review.
Qualifications:
- Degree in biological science or related discipline.
- B.S.: 10+ years relevant drug development experience; majority in regulatory affairs.
- M.S.: 10+ years relevant drug development experience; majority in regulatory affairs.
- M.D.: 7+ years relevant drug development; 5+ years in regulatory affairs.
- PhD/PharmD: 7+ years relevant drug development; 5+ years in regulatory affairs.
Required:
- 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 program experience (including pediatrics, orphan drug, expedited development).
- Experience with small and large molecule programs.
- Global regulatory experience (EU, China, Japan).
- Prior GRL oversight of global submissions/approvals (IND/CTAs, NDA/BLAs).
- Devices knowledge (inhalers, auto injectors, pre-filled syringes, etc.).
- Proficient in AI applications.
Required Skills:
- Pharmaceutical Regulatory Affairs; Regulatory Strategy/Strategy Development; Regulatory Issues/Compliance; Regulatory Communications/Management; Drug Development; Product Approvals; Process Improvements; Clinical Reporting; Written Communication; Global Health; In Vitro Diagnostics (IVD).
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.
- Develop and execute worldwide regulatory strategy for General Medicine programs (cardiovascular metabolic) to optimize labeling and obtain shortest time to approval for multiple indications simultaneously.
- Serve as Global Regulatory Lead (GRL): global point of contact for regulatory agencies/subsidiaries; provide strategic regulatory oversight across early- and late-stage development (including complex programs with multiple indications/formulations and external partners).
- Lead Global Regulatory Team (GRT) for assigned cardiovascular/renal/respiratory programs and coordinate global cross-functional regulatory support.
- Provide expert regulatory advice as GRL to Early Development and Product Development Teams within and external to Global Regulatory Affairs and Clinical Safety (GRACS) across the product lifecycle.
- Review and provide final approval of local registration study protocols for secondary markets.
- Communicate directly with FDA (calls/emails), chair meetings, and prepare teams for FDA meetings at any development phase.
- Coordinate with global regulatory agencies via Regulatory Affairs Europe/International and subsidiary registration departments to provide strategic direction across regions.
- Review and provide final approval of Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures before external release.
- Provide regulatory advice/approval in internal committees (e.g., document review, PDT/EDT, label development).
- Conduct initial IND/CSA content review and approval for clinical trial authorizations.
- Participate in regulatory due diligence for licensing candidate review.
Qualifications:
- Degree in biological science or related discipline.
- B.S.: 10+ years relevant drug development experience; majority in regulatory affairs.
- M.S.: 10+ years relevant drug development experience; majority in regulatory affairs.
- M.D.: 7+ years relevant drug development; 5+ years in regulatory affairs.
- PhD/PharmD: 7+ years relevant drug development; 5+ years in regulatory affairs.
Required:
- 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 program experience (including pediatrics, orphan drug, expedited development).
- Experience with small and large molecule programs.
- Global regulatory experience (EU, China, Japan).
- Prior GRL oversight of global submissions/approvals (IND/CTAs, NDA/BLAs).
- Devices knowledge (inhalers, auto injectors, pre-filled syringes, etc.).
- Proficient in AI applications.
Required Skills:
- Pharmaceutical Regulatory Affairs; Regulatory Strategy/Strategy Development; Regulatory Issues/Compliance; Regulatory Communications/Management; Drug Development; Product Approvals; Process Improvements; Clinical Reporting; Written Communication; Global Health; In Vitro Diagnostics (IVD).
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.