Global Regulatory Lead, Immunology

Merck; Olympia (WA); 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 projects. You will act as the global point of contact and coordinate with FDA, EMA, and affiliates to expedite labeling and approvals.

The role requires strong leadership, proactive management of complex programs, and deep immunology experience to guide development from IND to marketing authorization across multiple regions.

Qualifications

• B.S./M.S. in a relevant field with multiple years in drug development and regulatory work.
• MD/PhD/PharmD with several years in drug development and at least three in regulatory work.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and time-to-approval.
• Leads or supports interactions with major Health Authorities (FDA, EMA) globally.
• Coordinates submissions and follow-up with regulatory agencies and subsidiaries.

Skills

Global Regulatory

Drug Development

Regulatory Affairs Management

Regulatory Submissions

Strategic Leadership

Regulatory Communications

Regulatory Strategies

Regulatory Processes

Product Registrations

Pharmaceutical Industry

Education

B.S./M.S. in relevant field

MD/PhD/PharmD

Job description

Merck seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects. You will act as the global point of contact and coordinate with FDA, EMA, and affiliates to expedite labeling and approvals.

The role requires strong leadership, proactive management of complex programs, and deep immunology experience to guide development from IND to marketing authorization across multiple regions.