Remote Global Regulatory Lead, Immunology

Merck; Little Rock (AR); Remote; USD 191,000 - 300,000; Full time

Job summary

Merck seeks a Senior Director (Sr. Principal Scientist) in Regulatory Affairs Liaison to lead worldwide regulatory strategies for General Medicine immunology programs. You will act as the single global point of contact, guiding development teams and coordinating with FDA, EMA, and other agencies.

The role demands strategic thinking, independence, and strong leadership to optimize labeling and expedite approvals across multiple indications and partners.

Qualifications

• Strong regulatory leadership and global strategy development
• Experience with FDA, EMA and other major authorities
• Proven ability to lead cross-functional teams on regulatory submissions

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and shorten time to approval
• Acts as global regulatory lead to Product Development Teams
• Leads regulatory meetings with major Health Authorities (FDA, EMA) and prepares submissions
• Coordinates cross-functional regulatory support for development programs
• Provides expert regulatory advice throughout product life cycle
• Reviews and approves study protocols for marketing authorization in secondary markets
• Participates in regulatory due diligence for licensing
• Interacts with regulatory agencies and external partners independently

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Documents

Regulatory Processes

Regulatory Strategies

Regulatory Strategy Development

Regulatory Submissions

Strategic Leadership

Education

B.S. or M.S with minimum 10 years drug development experience (regulatory focus)

M.D. or PhD/PharmD with minimum 7 years drug development experience with regulatory focus

Job description

Merck seeks a Senior Director (Sr. Principal Scientist) in Regulatory Affairs Liaison to lead worldwide regulatory strategies for General Medicine immunology programs. You will act as the single global point of contact, guiding development teams and coordinating with FDA, EMA, and other agencies.

The role demands strategic thinking, independence, and strong leadership to optimize labeling and expedite approvals across multiple indications and partners.