Global Immunology Regulatory Lead — Remote

HireLifeScience; Cambridge (MA); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Job summary

Merck in the United States seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs, optimize labeling, and shorten time to approval.

You will manage global projects, interact with FDA/EMA, and coordinate with affiliates and external partners, serving as the primary regulatory contact.

This role requires strategic thinking, leadership, and a track record of global regulatory filings across major markets.

Qualifications

• BS or MS with 7+ years in drug development, regulatory focus.
• MD/PhD/PharmD with 5+ years, 3 in regulatory.
• Experience leading health authority interactions.
• Proven global regulatory filings leadership.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and approvals.
• Lead regulatory teams and coordinate with global authorities.
• Prepare submissions and respond to authorities for multiple programs.
• Interact with FDA/EMA and global affiliates on strategy.

Skills

Strategic thinking

Communication

Leadership

Regulatory affairs

Education

BS/MS

MD/PhD/PharmD

Job description

Merck in the United States seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs, optimize labeling, and shorten time to approval.

You will manage global projects, interact with FDA/EMA, and coordinate with affiliates and external partners, serving as the primary regulatory contact.

This role requires strategic thinking, leadership, and a track record of global regulatory filings across major markets.