Global Regulatory Lead for Cardiometabolic Programs

Merck; Rockville (MD); Híbrido; USD 160.000 - 230.000; Jornada completa

Descripción de la vacante

Merck & Co., Inc. seeks a Senior Principal Scientist, Regulatory Affairs Liaison, to lead worldwide regulatory strategy for General Medicine programs focusing on cardiovascular/metabolic development.

The role requires independent program management, strategic global oversight, and collaboration with FDA and regional authorities to accelerate approvals. The ideal candidate will have extensive regulatory experience, strong leadership, and a track record in managing complex multi-indication

Formación

• Degree in biological science or related discipline.

Responsabilidades

• Oversee global regulatory strategy development and execution for cardiovascular metabolic programs.
• Provide expert regulatory guidance as Global Regulatory Lead to cross-functional teams.
• Lead Global Regulatory Team coordination for development programs and marketed products.
• Approve local registration study protocols for marketing authorization in secondary markets.
• Represent company with FDA and coordinate meetings and regulatory communications.
• Coordinate interactions with global regulatory agencies to support global strategy across regions.
• Review and approve Worldwide Marketing Applications and related documents for external agencies.
• Participate in regulatory due diligence for licensing candidates.

Conocimientos

Biological Sciences

Clinical Reporting

Drug Development

Global Health

IVD (In Vitro Diagnostics)

Multiple Therapeutic Areas

Pharmaceutical Regulatory Affairs

Regulatory Affairs Management

Regulatory Communications

Regulatory Compliance

Regulatory Issues

Regulatory Strategies

Regulatory Strategy Development

Written Communication

Educación

Bachelor's degree in Biological Science

Master's degree in Biological Science

MD

PhD/PharmD

Descripción del empleo

Merck & Co., Inc. seeks a Senior Principal Scientist, Regulatory Affairs Liaison, to lead worldwide regulatory strategy for General Medicine programs focusing on cardiovascular/metabolic development.

The role requires independent program management, strategic global oversight, and collaboration with FDA and regional authorities to accelerate approvals. The ideal candidate will have extensive regulatory experience, strong leadership, and a track record in managing complex multi-indication