Global Regulatory Strategy Director, Immunology (Remote)

Merck; Jackson (MS); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays

Job summary

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to develop and implement worldwide regulatory strategies for Immunology programs. You will act as the global single point of contact on projects, guiding labeling optimization and shortest time to approval while coordinating with FDA, EMA and regional teams.

The role requires strong leadership, proactive management of complex programs, and extensive regulatory affairs experience, including interactions with health

Qualifications

• Minimum education: B.S. or M.S. with a minimum of 7 years of relevant drug development experience largely in regulatory.
• M.D. or PhD/PharmD with minimum 5 years relevant drug development experience with three years in regulatory.
• Strong strategic thinking and problem-solving mindset.
• Experience leading interactions with major Health Authorities (FDA, EMA).

Responsibilities

• Develop worldwide regulatory strategies to optimize labeling and shorten approval timelines.
• Assess regulatory/competitive landscape to set global strategies for speed-to-market and labeling.
• Serve as Global Regulatory Lead and point of contact for projects across lifecycle.
• Provide leadership to Global Regulatory Team coordinating cross-functional support.
• Coordinate preparation, submission and follow-up with regulatory agencies and subsidiaries.
• Review and approve local registration study protocols for marketing authorization.
• Interact independently with regulatory agencies (FDA, EMA) including meetings and communications.
• Coordinate regional regulatory strategy with RA Europe and local affiliates.
• Review Worldwide Marketing Applications, Clinical Study Reports, and Investigator Brochures.
• Prepare IND/CTAs for global studies and participate in regulatory due diligence.

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 relevant field

M.D./Ph.D./PharmD with regulatory experience

Job description

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to develop and implement worldwide regulatory strategies for Immunology programs. You will act as the global single point of contact on projects, guiding labeling optimization and shortest time to approval while coordinating with FDA, EMA and regional teams.

The role requires strong leadership, proactive management of complex programs, and extensive regulatory affairs experience, including interactions with health