Remote Global Regulatory Lead (Immunology)

Merck; Dover; Remote; GBP 130,000 - 204,000; Full time

Job summary

Merck seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs. You will act as the global single point of contact, advise development teams, and drive submissions with regulators (FDA/EMA) across life cycles.

The role requires senior-level regulatory expertise, strategic thinking, and strong communication skills to coordinate with regional affiliates and external partners. Remote work options may be available with travel.

Qualifications

• Requires leadership of global regulatory programs across multiple indications and products.
• Experience coordinating with health authorities (FDA, EMA) and cross-functional teams.
• Immunology therapeutic area knowledge is preferred.

Responsibilities

• Develops global regulatory strategies to optimize timing of approvals.
• Leads regulatory filings and interactions with authorities worldwide.
• Provides expert regulatory guidance to product development teams.
• Coordinates regulatory submissions and tracks follow-up actions.
• Reviews documentation for marketing authorisation in various regions.

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

Bachelor-level degree (B.S./M.S.) in a relevant field

M.D. or PhD/PharmD with regulatory experience

Job description

Merck seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs. You will act as the global single point of contact, advise development teams, and drive submissions with regulators (FDA/EMA) across life cycles.

The role requires senior-level regulatory expertise, strategic thinking, and strong communication skills to coordinate with regional affiliates and external partners. Remote work options may be available with travel.