Remote Global Regulatory Strategist – Immunology

Merck; Denver (CO); 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 and optimize labeling for fastest approvals. You will act as the global single point of contact and interact with health authorities across regions.

The role requires strategic thinking, strong communication, and proven experience with major Health Authorities. Travel is expected; remote work options may apply.

Qualifications

• B.S. or M.S. with minimum 7 years in drug development, majority in regulatory.
• M.D. or Ph.D./PharmD with minimum 5 years in drug development, with 3 years in regulatory.

Responsibilities

• Develop worldwide regulatory strategies to optimize labeling and accelerate approvals.
• Lead regulatory teams and coordinate submissions with global agencies.
• Interact with FDA, EMA, and other authorities on regulatory issues and meetings.
• Coordinate regional regulatory strategy with Europe and local affiliates.
• Prepare IND/CTAs for global studies and oversee study documentation.
• Review global marketing applications and clinical study reports.

Skills

Drug Development

Global Regulatory

Regulatory Affairs

Regulatory Submissions

Regulatory Strategy

Regulatory Communications

Strategic Leadership

Education

Bachelor's degree in a relevant field

MD/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 and optimize labeling for fastest approvals. You will act as the global single point of contact and interact with health authorities across regions.

The role requires strategic thinking, strong communication, and proven experience with major Health Authorities. Travel is expected; remote work options may apply.