Sr. Principal Scientist (Sr. Director) - Regulatory Liaison
Merck
July 01, 2026
Remote friendly (North Wales, PA)
United States
Corporate Functions
Senior Principal Scientist, Regulatory Affairs Liaison
Primary Activities:
- Oversee development and execution of global regulatory strategy for cardiovascular metabolic programs to optimize labeling and shortest time to approval.
- Serve as Global Regulatory Lead (GRL) and regulatory single point of contact; independently manage assigned programs across early/late-stage development.
- Provide expert regulatory advice to Early/Product Development Teams and as liaison across Global Regulatory Affairs and Clinical Safety.
- Lead the Global Regulatory Team (GRT) for assigned cardiovascular/renal/respiratory programs; coordinate cross-functional regulatory support.
- Review/approve local registration study protocols (secondary markets) and approve Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures.
- Chair/prepare for FDA interactions; coordinate with global agencies via regional/regional registration groups.
- Conduct initial IND/CSA content review/approval; participate in regulatory due diligence for licensing candidates.
Minimum Education & Experience:
- Degree in biological science or related discipline.
- B.S./M.S.: 10+ years relevant drug development experience (majority in regulatory affairs); or M.D./PhD/PharmD: 7+ years relevant experience with 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; building/leading high-performing teams.
Preferred:
- Cardiovascular/renal/respiratory development (incl. pediatrics, orphan, expedited); small/large molecule experience.
- Global market regulatory experience (EU/China/Japan); prior GRL oversight (IND/CTA, NDA/BLA).
- Device knowledge; proficiency in AI applications.
Required Skills (examples): Drug development, regulatory strategies/development, regulatory compliance/communications/management, product approvals.
Compensation & Benefits:
- Salary range: $190,800.00–$300,300.00; eligible for annual bonus/long-term incentive if applicable; comprehensive benefits including medical/dental/vision and 401(k).
Application Instructions:
- Apply via https://jobs.merck.com/us/en. Job posting end date: 07/24/2026 (apply no later than 11:59:59PM the day before).
Primary Activities:
- Oversee development and execution of global regulatory strategy for cardiovascular metabolic programs to optimize labeling and shortest time to approval.
- Serve as Global Regulatory Lead (GRL) and regulatory single point of contact; independently manage assigned programs across early/late-stage development.
- Provide expert regulatory advice to Early/Product Development Teams and as liaison across Global Regulatory Affairs and Clinical Safety.
- Lead the Global Regulatory Team (GRT) for assigned cardiovascular/renal/respiratory programs; coordinate cross-functional regulatory support.
- Review/approve local registration study protocols (secondary markets) and approve Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures.
- Chair/prepare for FDA interactions; coordinate with global agencies via regional/regional registration groups.
- Conduct initial IND/CSA content review/approval; participate in regulatory due diligence for licensing candidates.
Minimum Education & Experience:
- Degree in biological science or related discipline.
- B.S./M.S.: 10+ years relevant drug development experience (majority in regulatory affairs); or M.D./PhD/PharmD: 7+ years relevant experience with 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; building/leading high-performing teams.
Preferred:
- Cardiovascular/renal/respiratory development (incl. pediatrics, orphan, expedited); small/large molecule experience.
- Global market regulatory experience (EU/China/Japan); prior GRL oversight (IND/CTA, NDA/BLA).
- Device knowledge; proficiency in AI applications.
Required Skills (examples): Drug development, regulatory strategies/development, regulatory compliance/communications/management, product approvals.
Compensation & Benefits:
- Salary range: $190,800.00–$300,300.00; eligible for annual bonus/long-term incentive if applicable; comprehensive benefits including medical/dental/vision and 401(k).
Application Instructions:
- Apply via https://jobs.merck.com/us/en. Job posting end date: 07/24/2026 (apply no later than 11:59:59PM the day before).