Global Regulatory Lead, Immunology: Strategy & Approvals

Merck; Dover (DE); Remote; USD 191,000 - 300,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Job summary

Merck seeks a Senior Director, Regulatory Affairs Liaison, to lead worldwide regulatory strategies for General Medicine with a focus on Immunology. You will act as the global sole point of contact on project teams, advising Product Development and coordinating with FDA/EMA to optimize labeling and time-to-approval across markets.

The role requires strategic leadership, independence, and experience across US, EU, Japan, and China.

Qualifications

• Experience leading regulatory strategies across global regions.
• Interactions with major Health Authorities (FDA/EMA) preferred.
• Global regulatory affairs across U.S., EU, Japan, China.

Responsibilities

• Develop worldwide regulatory strategies to optimize labeling and speed approvals.
• Provide regulatory lead for Product Development Teams across lifecycle.
• Coordinate preparation and submission of global regulatory documentation.
• Lead cross-functional regulatory teams and interface with agencies.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Documents

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Leadership

Education

B.S. or M.S. with 10+ years in drug development (regulatory focus)

M.D. or Ph.D./Pharm.D. with 7+ years in drug development (regulatory)

Job description

Merck seeks a Senior Director, Regulatory Affairs Liaison, to lead worldwide regulatory strategies for General Medicine with a focus on Immunology. You will act as the global sole point of contact on project teams, advising Product Development and coordinating with FDA/EMA to optimize labeling and time-to-approval across markets.

The role requires strategic leadership, independence, and experience across US, EU, Japan, and China.