Global Regulatory Lead - Immunology (Remote)

Merck; Topeka (KS); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Annual bonus and long-term incentive

Comprehensive benefits package

Remote work flexibility

Job summary

Merck & Co., Inc. is seeking a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects.

You will serve as the global single point of contact, guiding labeling optimization and fastest approvals with regulatory agencies. Ideal candidates bring experience in immunology and a record of leading regulatory filings across global regions, including major authorities.

Qualifications

• Requires strong regulatory leadership in global programs.
• Experience leading interactions with major Health Authorities (FDA/EMA).
• Proven track record in global regulatory filings and lifecycle management.

Responsibilities

• Develop worldwide regulatory strategies to optimize labeling and time to approval.
• Coordinate with regional teams for submissions and regulatory reviews.
• Lead regulatory team and cross-functional programs across product lifecycles.
• Interact with regulatory agencies and subsidiaries on strategy and registrations.
• Prepare and follow up on regulatory applications and documentation.
• Provide expert advice as global regulatory lead for development programs.

Skills

Drug Development

Global Regulatory

Regulatory Affairs Management

Regulatory Submissions

Strategic Leadership

Regulatory Communications

Regulatory Strategies

Regulatory Processes

Product Registrations

Pharmaceutical Industry

Cross-functional Collaboration

Education

B.S. or M.S. with 7 years drug development experience

M.D. or PhD/PharmD with 5 years regulatory experience

Job description

Merck & Co., Inc. is seeking a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects.

You will serve as the global single point of contact, guiding labeling optimization and fastest approvals with regulatory agencies. Ideal candidates bring experience in immunology and a record of leading regulatory filings across global regions, including major authorities.