Global Regulatory Lead, Immunology (Remote)

Merck; Tallahassee (FL); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) with company match

Paid holidays and vacation

Job summary

Merck invites a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects. This senior role oversees regulatory activities, coordinates with global agencies, and guides labeling to accelerate approvals.

Strong immunology experience and cross-functional leadership are highly valued. The role requires strategic thinking, proactive project management, and collaboration across global teams to ensure successful regulatory outcomes across

Qualifications

• B.S. or M.S. with at least 7 years in drug development and regulatory
• M.D. or PhD/PharmD with at least 5 years drug development experience including 3 in regulatory
• Experience interacting with major Health Authorities (FDA, EMA) preferred

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and approval timelines
• Leads regulatory team and coordinates cross-functional support for development and marketed products
• Interacts with regulatory agencies for submissions, meetings, and communications
• Reviews global regulatory filings and ensures lifecycle management

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Regulatory Affairs Management

Regulatory Submissions

Strategic Leadership

Regulatory Communications

Education

B.S./M.S. with 7+ yrs experience

M.D./PhD/PharmD with 5+ yrs regulatory

Job description

Merck invites a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects. This senior role oversees regulatory activities, coordinates with global agencies, and guides labeling to accelerate approvals.

Strong immunology experience and cross-functional leadership are highly valued. The role requires strategic thinking, proactive project management, and collaboration across global teams to ensure successful regulatory outcomes across