Global Regulatory Lead - Cardiovascular Metabolic Programs

Merck; Boston (MA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Merck & Co., Inc. in the United States is seeking a Senior Principal Scientist, Regulatory Affairs Liaison to lead worldwide regulatory strategy for General Medicine programs, with focus on cardiovascular/metabolic development. The role emphasizes independence, strategic oversight, and interactions with global agencies to optimize labeling and time-to-approval across multiple regions. Hybrid work arrangement is offered.

Qualifications

• Degree in biological science or related discipline.
• Clinical reporting and regulatory affairs experience preferred.
• Experience leading regulatory strategy for drug development programs.

Responsibilities

• Oversee global regulatory strategy development for cardiovascular metabolic programs.
• Lead the Global Regulatory Team coordinating cross-functional regulatory support.
• Interface with FDA and global agencies to optimize labeling and approval timelines.
• Review/approve study protocols and regulatory submissions as needed.
• Represent the company in regulatory discussions across multiple regions.

Skills

Biological Sciences

Clinical Reporting

Drug Development

Global Health

Regulatory Affairs

Regulatory Strategy

Written Communication

Regulatory Compliance

Regulatory Issues

Regulatory Strategies

Product Approvals

Education

B.S. in Biological Science

M.S. in Biological Science

M.D.

Ph.D./PharmD

Job description

Merck & Co., Inc. in the United States is seeking a Senior Principal Scientist, Regulatory Affairs Liaison to lead worldwide regulatory strategy for General Medicine programs, with focus on cardiovascular/metabolic development. The role emphasizes independence, strategic oversight, and interactions with global agencies to optimize labeling and time-to-approval across multiple regions. Hybrid work arrangement is offered.