Global Regulatory Liaison Director - Immunology (Remote)

Merck; Augusta (ME); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

Retirement benefits (401(k))

Remote work flexibility

Job summary

Merck in Rahway, NJ seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs. You will act as the single global contact, coordinating with FDA, EMA, and subsidiaries to optimize labeling and time-to-approval across indications.

The role requires proactive leadership, strong communication, and extensive experience in regulatory affairs, with a preference for immunology expertise and successful global filings.

Qualifications

• Strong strategic thinking and problem-solving skills.
• Experience interacting with major Health Authorities (FDA, EMA).
• Leadership of regulatory filings across global regions.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and approval timelines.
• Leads regulatory teams and coordinates cross-functional support for programs.
• Manages submissions and communications with global regulators.
• Reviews study protocols for marketing authorization in secondary markets.
• Interacts with regulatory agencies independently, leading meetings and written communications.
• Coordinates regional strategy with Europe (RAE) and affiliates.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Leadership

Education

B.S./M.S. in a related field

M.D. or PhD/PharmD

Job description

Merck in Rahway, NJ seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs. You will act as the single global contact, coordinating with FDA, EMA, and subsidiaries to optimize labeling and time-to-approval across indications.

The role requires proactive leadership, strong communication, and extensive experience in regulatory affairs, with a preference for immunology expertise and successful global filings.