Global Regulatory Lead, Cardiovascular/Metabolic Programs

Merck; Rahway (NJ); Hybrid; USD 191,000 - 300,000; Full time

Job summary

Merck in Rahway, NJ seeks a Senior Principal Scientist, Regulatory Affairs Liaison to lead worldwide regulatory strategy for General Medicine programs with focus on cardiovascular/metabolic development. This role demands strategic oversight across phases and global agencies to optimize labeling and accelerate approvals.

The candidate must direct the Global Regulatory Team, interact with FDA, and coordinate with Europe and international affiliates, ensuring robust regulatory pathways for multiple

Qualifications

• Degree in biological science or related discipline
• B.S. with minimum of 10 years relevant drug development experience, with a majority in regulatory affairs
• M.S. with minimum of 10 years relevant drug development experience, with a majority in regulatory affairs
• M.D. with minimum of 7 years relevant drug development experience, with 5 years in regulatory affairs
• PhD/PharmD with minimum of 7 years relevant drug development experience, with 5 years in regulatory affairs
• Ability to achieve optimal results with limited day-to-day direction from the Therapeutic Area Lead
• Outstanding interpersonal, verbal and written communication, and negotiation skills.
• Demonstrated leadership attributes, including experience building and leading high-performing teams.

Responsibilities

• Oversee the global regulatory strategy development and execution for assigned programs to optimize labeling and time to approval.
• Provide expert regulatory advice to EDT/PDT and acts as single point of contact for programs.
• Lead Global Regulatory Team coordinating cross-functional regulatory support.
• Review and approve local registration study protocols for marketing authorization.
• Represent company with FDA; chair meetings; prepare teams for meetings with FDA.
• Coordinate with Regulatory Affairs Europe, International, and subsidiaries for regional strategy.
• Review and approve Worldwide Marketing Applications, Clinical Study Reports, and related documents.
• Represent Regulatory Affairs in internal committees and document reviews.
• Conduct initial IND/CSA content review to enable trials; participate in licensing due diligence.

Skills

Biological Sciences

Clinical Reporting

Drug Development

Global Health

In Vitro Diagnostics (IVD)

Multiple Therapeutic Areas

Pharmaceutical Regulatory Affairs

Process Improvements

Product Approvals

Regulatory Affairs Compliance

Regulatory Affairs Management

Regulatory Communications

Regulatory Compliance

Regulatory Issues

Regulatory Strategies

Regulatory Strategy Development

Written Communication

Education

Bachelor's degree in Biological Science or related

M.S. with 10+ years regulatory experience

M.D. with 7+ years regulatory experience

PhD/PharmD with 7+ years regulatory experience

Job description

Merck in Rahway, NJ seeks a Senior Principal Scientist, Regulatory Affairs Liaison to lead worldwide regulatory strategy for General Medicine programs with focus on cardiovascular/metabolic development. This role demands strategic oversight across phases and global agencies to optimize labeling and accelerate approvals.

The candidate must direct the Global Regulatory Team, interact with FDA, and coordinate with Europe and international affiliates, ensuring robust regulatory pathways for multiple