Remote Global Regulatory Lead – Immunology

Merck; Bismarck (ND); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

Paid Holidays

Job summary

Merck seeks a Director (Principal Scientist), Global Regulatory Liaison to develop and implement worldwide regulatory strategies for Immunology projects. You will lead as the global point of contact, coordinating with authorities and cross-functional teams to optimize labeling and accelerate approvals.

This role requires proactive leadership, strong communication, and extensive experience with major health authorities.

Qualifications

• Minimum education: B.S. or M.S. with 7+ years in drug development/regulatory roles.
• Alternative: M.D. or PhD/PharmD with 5+ years, including regulatory experience.
• Experience leading interactions with Health Authorities (FDA, EMA) preferred.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and time to approval.
• Leads regulatory submissions and interactions with agencies globally.
• Acts as global single point of contact on regulatory issues for development programs.
• Coordinates cross-functional regulatory support and regional strategy.
• Reviews study protocols and supports marketing authorization in secondary markets.

Skills

Drug Development

Global Regulatory

Pharma Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs

Regulatory Communications

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Leadership

Education

B.S./M.S.

M.D./PhD/PharmD

Job description

Merck seeks a Director (Principal Scientist), Global Regulatory Liaison to develop and implement worldwide regulatory strategies for Immunology projects. You will lead as the global point of contact, coordinating with authorities and cross-functional teams to optimize labeling and accelerate approvals.

This role requires proactive leadership, strong communication, and extensive experience with major health authorities.