Global Immunology Regulatory Scientist (Remote)

Merck; Montgomery (AL); Remote; USD 173,000 - 273,000; Full time

Job summary

Merck & Co., Inc. seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects. You will drive labeling optimization and shorten approval timelines with global agencies.

A strong leader will manage cross-functional teams and partner with FDA/EMA on submissions. Experience in immunology and global regulatory affairs is highly preferred. This senior role offers a comprehensive benefits package and remote-friendly work

Qualifications

• BS or MS with a minimum of 7 years in drug development and regulatory work.
• MD/PhD/PharmD with at least 5 years in drug development and 3 years in regulatory.

Responsibilities

• Develops and implements global regulatory strategies to optimize labeling and accelerate approvals.
• Serves as the global regulatory lead and primary contact for project teams.
• Interacts with major health authorities (FDA, EMA) and regulatory agencies worldwide.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Regulatory Submissions

Regulatory Affairs Management

Regulatory Strategies

Regulatory Communications

Regulatory Processes

Strategic Leadership

Education

BS or MS in a relevant field

MD/PhD/PharmD with regulatory experience

Job description

Merck & Co., Inc. seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects. You will drive labeling optimization and shorten approval timelines with global agencies.

A strong leader will manage cross-functional teams and partner with FDA/EMA on submissions. Experience in immunology and global regulatory affairs is highly preferred. This senior role offers a comprehensive benefits package and remote-friendly work