Global Regulatory Scientist: Immunology & Liaison

Merck; Frankfort (KY); Remote; USD 173,000 - 273,000; Full time

Job summary

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects. You will drive labeling optimization and accelerate approvals by engaging FDA, EMA, and affiliates across geographies.

The role requires independent project management, strategic thinking, and strong leadership to align development programs with global regulatory expectations.

Qualifications

• 7+ years of drug development experience with regulatory focus.
• 5+ years of regulatory drug development experience for MD/PhD track.

Responsibilities

• Develops global regulatory strategies to optimize labeling and shorten time to approval.
• Coordinate regulatory submissions and liaise with FDA, EMA, and regional affiliates.
• Provide regulatory leadership to product development teams and act as global single point of contact for regulatory issues.
• Lead the Global Regulatory Team to coordinate cross-functional regulatory support.
• Prepare IND/CTAs and manage submissions, with regulatory review and approvals.
• Interact with regulatory agencies, lead meetings, and manage written communications.

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. or M.S in relevant field

M.D. or PhD/PharmD with regulatory experience

Job description

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects. You will drive labeling optimization and accelerate approvals by engaging FDA, EMA, and affiliates across geographies.

The role requires independent project management, strategic thinking, and strong leadership to align development programs with global regulatory expectations.