Global Regulatory Liaison Director - Immunology (Remote)

Merck; Atlanta (GA); Remote; USD 173,000 - 273,000; Full time

Job summary

Merck seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs, aiming to shorten approval times with global agencies. The role requires independent project management as the global contact on teams, interactions with FDA/EMA, and leadership of cross-functional regulatory efforts across lifecycle stages.

Experience in immunology and global regulatory filings across major markets is strongly preferred, with travel up to 10%

Qualifications

• Strong strategic thinking, problem-solving, and continuous learning mindset.
• Effective communicator—both written and verbal—with the ability to influence, lead, and negotiate across levels and functions.
• Experience leading or supporting direct interactions with major Health Authorities (FDA, EMA).
• Demonstrated expertise in leading regulatory filings across global regions.
• Therapeutic area expertise in immunology.
• Small and large molecule experience.
• Regulatory affairs experience in major markets (U.S., EU, Japan, China).

Responsibilities

• Develops worldwide product regulatory strategies to optimize labeling and obtain shortest time to approval by regulatory agencies for assigned indications.
• Assesses regulatory/competitive landscape to establish global regulatory strategies that facilitate speed-to-market and the delivery of targeted product labeling.
• Provides expert advice as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within and external to GRACS on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.
• Provides leadership to the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.
• Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions and responsible for regulatory review and final approval for all submissions and associated documentation.
• Reviews Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures.
• Prepares IND/CTAs for global studies related to investigational drugs/biologics.
• Participates in regulatory due diligence activities for licensing candidate reviews.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Leadership

Immunology

Education

B.S./M.S. with 7+ years in drug development

M.D./PhD/PharmD with 5+ years regulatory

Job description

Merck seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs, aiming to shorten approval times with global agencies. The role requires independent project management as the global contact on teams, interactions with FDA/EMA, and leadership of cross-functional regulatory efforts across lifecycle stages.

Experience in immunology and global regulatory filings across major markets is strongly preferred, with travel up to 10%