Global Regulatory Strategy Director - Remote

Merck; Madison (WI); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement benefits

Job summary

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison in the United States. This role leads worldwide regulatory strategies and provides global regulatory oversight for multiple programs across immunology, with a focus on speed-to-market and labeling optimization.

The incumbent serves as the global point of contact for project teams, coordinating with FDA/EMA and affiliates, and guiding regulatory strategy throughout product lifecycles.

Qualifications

• Strong strategic thinking and problem-solving mindset.
• Effective written and verbal communicator with influence and negotiation skills.
• Experience leading or supporting direct interactions with major Health Authorities (FDA, EMA).
• Demonstrated expertise in leading regulatory filings across global regions.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and time-to-approval.
• Leads or supports global regulatory filings and interacts with authorities.
• Provides leadership to cross-functional Regulatory Team across development programs.
• Coordinates regulatory submissions and associated documentation with agencies.
• Reviews study protocols for marketing authorization in secondary markets.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Leadership

Immunology

Education

B.S. or M.S with a minimum of 7 years of relevant drug development experience

M.D. or PhD/PharmD with a minimum of 5 years relevant drug development experience with three years in regulatory

Job description

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison in the United States. This role leads worldwide regulatory strategies and provides global regulatory oversight for multiple programs across immunology, with a focus on speed-to-market and labeling optimization.

The incumbent serves as the global point of contact for project teams, coordinating with FDA/EMA and affiliates, and guiding regulatory strategy throughout product lifecycles.