Global Regulatory Strategy Director, Immunology — Remote

Merck; Columbus (OH); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Retirement benefits / 401(k)

Paid holidays and vacation

Job summary

Merck seeks a Director (Principal Scientist), Global Regulatory Liaison to shape worldwide regulatory strategies for Immunology programs. You will lead regulatory filings, coordinate with agencies and internal teams to accelerate labeling and approval timelines.

Responsibilities include acting as the global regulatory lead, guiding development programs, and interfacing with health authorities to ensure compliant, timely submissions across geographies. Immunology experience preferred.

Qualifications

• Experience leading regulatory filings across global regions.
• Strong strategic thinking and problem-solving mindset.
• Effective written and verbal communication to influence across levels.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and speed approvals.
• Acts as global regulatory lead and single point of contact on teams.
• Interacts with FDA, EMA and other agencies; leads meetings and written communications.
• Coordinates submissions and regional strategy with cross-functional teams.

Skills

Global Regulatory

Regulatory Strategy

Drug Development

Regulatory Submissions

Communication

Leadership

Education

BS/MS in pharmacology or related field

MD/PhD/PharmD with regulatory experience

Job description

Merck seeks a Director (Principal Scientist), Global Regulatory Liaison to shape worldwide regulatory strategies for Immunology programs. You will lead regulatory filings, coordinate with agencies and internal teams to accelerate labeling and approval timelines.

Responsibilities include acting as the global regulatory lead, guiding development programs, and interfacing with health authorities to ensure compliant, timely submissions across geographies. Immunology experience preferred.