Sr. Principal Scientist (Sr. Director) - Regulatory Liaison
Merck
July 01, 2026
Remote friendly (Rockville, MD)
United States
Corporate Functions
Senior Principal Scientist, Regulatory Affairs Liaison (General Medicine)
Primary Activities Include (but are not limited to):
- Oversee worldwide regulatory strategy development/execution for cardiovascular metabolic programs; optimize labeling and shortest time to approval for multiple indications.
- Serve as Global Regulatory Lead (GRL): global regulatory single point-of-contact; interact with agencies/subsidiaries on global strategy/registration for investigational/marketed drugs/biologics throughout the lifecycle.
- Lead Global Regulatory Team (GRT) for assigned cardiovascular/renal/respiratory programs.
- Review/approve local registration study protocols (secondary markets) and provide final approval for Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures.
- Chair/coordinate FDA communications (calls, email, meetings); prepare internal teams for FDA meetings.
- Conduct initial IND/CSA content review/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:
- Deliver optimal results with limited day-to-day direction.
- Exceptional interpersonal, verbal/written communication, and negotiation.
- Leadership: build/lead 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/CTA; NDA/BLA); device knowledge; AI proficiency.
Required Skills:
- Pharmaceutical Regulatory Affairs, regulatory strategy/development, compliance, regulatory issues/comms, drug development, product approvals, process improvements, written communication.
Compensation/Benefits (explicit):
- Eligible for annual bonus and long-term incentive (if applicable).
- Medical/dental/vision, retirement (401(k)), paid holidays/vacation, and compassionate/sick days.
Application Instructions:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub). Deadline: stated on the posting.
Primary Activities Include (but are not limited to):
- Oversee worldwide regulatory strategy development/execution for cardiovascular metabolic programs; optimize labeling and shortest time to approval for multiple indications.
- Serve as Global Regulatory Lead (GRL): global regulatory single point-of-contact; interact with agencies/subsidiaries on global strategy/registration for investigational/marketed drugs/biologics throughout the lifecycle.
- Lead Global Regulatory Team (GRT) for assigned cardiovascular/renal/respiratory programs.
- Review/approve local registration study protocols (secondary markets) and provide final approval for Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures.
- Chair/coordinate FDA communications (calls, email, meetings); prepare internal teams for FDA meetings.
- Conduct initial IND/CSA content review/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:
- Deliver optimal results with limited day-to-day direction.
- Exceptional interpersonal, verbal/written communication, and negotiation.
- Leadership: build/lead 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/CTA; NDA/BLA); device knowledge; AI proficiency.
Required Skills:
- Pharmaceutical Regulatory Affairs, regulatory strategy/development, compliance, regulatory issues/comms, drug development, product approvals, process improvements, written communication.
Compensation/Benefits (explicit):
- Eligible for annual bonus and long-term incentive (if applicable).
- Medical/dental/vision, retirement (401(k)), paid holidays/vacation, and compassionate/sick days.
Application Instructions:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub). Deadline: stated on the posting.