Remote Global Regulatory Leader, Immunology Strategy

Merck; Baton Rouge (LA); Remote; USD 173,000 - 273,000; Full time

Job summary

Merck & Co., Inc. seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs, oversee submissions, and drive fastest paths to approval with global agencies.

This role requires independent project management, interaction with FDA/EMA, and leadership of a cross-functional team across regions, with strong immunology experience.

Qualifications

• B.S. or M.S with at least 7 years in drug development, primarily regulatory.
• M.D. or PhD/PharmD with at least 5 years in drug development, including 3 years in regulatory.
• Strong strategic thinking, problem-solving, and continuous learning mindset.
• Effective written and verbal communicator with ability to influence and negotiate across levels.
• Experience leading interactions with major Health Authorities (FDA, EMA).
• Demonstrated expertise in leading regulatory filings across global regions.
• Immunology therapeutic area expertise.
• Small and large molecule experience.
• Regulatory affairs experience in major markets (US, EU, Japan, China).

Responsibilities

• Develops worldwide 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.
• 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.
• Interact independently with regulatory agencies (FDA, EMA), including leading meetings, teleconferences, and written communications.
• Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams.
• Reviews Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures.

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. or M.S with minimum 7 years in drug development (regulatory focused)

MD or PhD/PharmD with minimum 5 years in drug development and 3 years in regulatory

Job description

Merck & Co., Inc. seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs, oversee submissions, and drive fastest paths to approval with global agencies.

This role requires independent project management, interaction with FDA/EMA, and leadership of a cross-functional team across regions, with strong immunology experience.