Remote Global Regulatory Lead - Immunology

Merck; Pierre (SD); Remote; USD 173,000 - 273,000; Full time

Job summary

Merck & Co., Inc. in the United States seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs, optimizing labeling and expediting approvals.

The role requires independent management of projects, interaction with global regulators, and leadership of cross‑functional teams across development stages through lifecycle oversight. Applicants will need strong communication skills and a track record of successful global

Qualifications

• Minimum Education & Experience: B.S./M.S with 7+ years of drug development experience; M.D./Ph.D./PharmD with 5+ years in regulatory.
• Experience leading regulatory filings across global regions and interacting with major Health Authorities (e.g., FDA, EMA).
• Strong strategic thinking, problem-solving, and leadership in regulatory programs.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and expedite approvals.
• Leads the Global Regulatory Team and coordinates cross-functional regulatory support.
• Interacts with regulatory agencies (FDA, EMA) and regional teams; manages submissions and approvals.

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 of relevant drug development experience

M.D./Ph.D./PharmD with 5+ years of experience in regulatory

Job description

Merck & Co., Inc. in the United States seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs, optimizing labeling and expediting approvals.

The role requires independent management of projects, interaction with global regulators, and leadership of cross‑functional teams across development stages through lifecycle oversight. Applicants will need strong communication skills and a track record of successful global