Global Regulatory Lead, Immunology Strategy

Merck; Nashville (TN); Remote; USD 191,000 - 300,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Vacation

Sick days

Remote work option

Job summary

Merck is seeking a Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison to lead worldwide regulatory strategies for immunology programs. The role serves as the global regulatory lead for development teams, coordinating with FDA/EMA and other agencies to optimize labeling and accelerate time to market.

Strong leadership and cross-functional collaboration are essential. Responsibilities include directing regulatory strategy, preparing submissions, and guiding regulatory activities

Qualifications

• B.S. or M.S in a science with 10+ years in drug development/regulatory
• M.D. or PhD/PharmD with 7+ years and regulatory focus
• Experience with major Health Authorities (FDA/EMA) and global regulatory strategy
• Strong strategic thinking, leadership, and cross-functional influence

Responsibilities

• Develop worldwide regulatory strategies to optimize labeling and speed approvals.
• Lead global regulatory team and coordinate cross-functional support for development programs and marketed products.
• Interact with regulatory agencies (FDA, EMA) and lead regulatory meetings.
• Prepare IND/CTAs and regulatory submissions for global studies.
• Support regulatory due diligence for licensing candidates and partner programs.
• Provide expert regulatory advice to Product Development Teams and act as single-point contact.
• Guide cross-functional teams through regulatory life-cycle requirements.

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

Immunology

Education

B.S. or M.S

M.D. or PhD/PharmD

Job description

Merck is seeking a Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison to lead worldwide regulatory strategies for immunology programs. The role serves as the global regulatory lead for development teams, coordinating with FDA/EMA and other agencies to optimize labeling and accelerate time to market.

Strong leadership and cross-functional collaboration are essential. Responsibilities include directing regulatory strategy, preparing submissions, and guiding regulatory activities