Global Regulatory Immunology Lead (Remote)

Merck; Columbus (OH); Remote; USD 180,000 - 273,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Vacation days

Sick days

Job summary

Merck & Co., Inc. is seeking a Director (Principal Scientist), Global Regulatory Liaison to develop and implement worldwide regulatory strategies for Immunology programs.

The role serves as the global single point of contact for regulatory affairs and coordinates interactions with major authorities to accelerate approvals. Candidate should have strong leadership, strategic thinking, and experience in leading regulatory filings across global regions, with preference for immunology expertise and

Qualifications

• Strong drug development and regulatory strategy experience required.
• Experience leading regulatory filings across global regions preferred.
• Immunology experience is strongly preferred.

Responsibilities

• Develop worldwide regulatory strategies to optimize labeling and approvals.
• Lead cross-functional teams on regulatory programs for development and life-cycle.
• Interact with FDA, EMA and other agencies as global single point of contact.
• Coordinate submissions and ensure regulatory review and approvals.
• Provide expert regulatory guidance to product development teams.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Leadership

Education

B.S. or M.S. in relevant field

M.D. or PhD/PharmD with regulatory experience

Job description

Merck & Co., Inc. is seeking a Director (Principal Scientist), Global Regulatory Liaison to develop and implement worldwide regulatory strategies for Immunology programs.

The role serves as the global single point of contact for regulatory affairs and coordinates interactions with major authorities to accelerate approvals. Candidate should have strong leadership, strategic thinking, and experience in leading regulatory filings across global regions, with preference for immunology expertise and