Global Regulatory Lead, Immunology

Merck; Indianapolis (IN); Remote; USD 173,000 - 273,000; Full time

Job summary

Merck & Co., Inc. is seeking a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs.

You will serve as the global single point of contact, drive labeling optimization, and shorten time to approval with major regulatory agencies while guiding cross-functional teams across development to commercialization. The role requires independent project leadership, strong communication, and extensive experience with health authorities.

Qualifications

• BS/MS with 7+ years of drug development/regulatory experience.
• MD/PhD/PharmD with 5+ years of regulatory experience.
• Experience interacting with major health authorities (FDA/EMA).
• Demonstrated ability to lead global regulatory filings across regions.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and shorten approval times.
• Lead global regulatory teams and coordinate regulatory submissions across regions.
• Interact with FDA, EMA and other agencies; lead meetings and communications.
• Coordinate regional regulatory strategy with affiliates and Europe (RAE).
• Prepare INDs/CTAs and oversee lifecycle regulatory activities.

Skills

Global Regulatory

Regulatory Submissions

Strategic Leadership

Regulatory Affairs Management

Drug Development

Education

BS/MS with 7+ years

MD/PhD/PharmD with 5+ years

Job description

Merck & Co., Inc. is seeking a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs.

You will serve as the global single point of contact, drive labeling optimization, and shorten time to approval with major regulatory agencies while guiding cross-functional teams across development to commercialization. The role requires independent project leadership, strong communication, and extensive experience with health authorities.