Global Regulatory Lead - Immunology, Remote

Merck; Lansing (MI); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement benefits

Remote work option

Job summary

Merck in USA (Rahway) seeks a Director (Principal Scientist) for Global Regulatory Liaison to drive worldwide regulatory strategies for Immunology projects and to optimize labeling and time-to-approval with global agencies. You will manage complex programs, lead cross-functional teams, and serve as the primary global contact on regulatory issues throughout the drug life cycle.

Preferred immunology experience with a track record in leading regulatory filings, strategic thinking, and effective

Qualifications

• BS or MS with 7+ years of drug development experience in regulatory or related areas.
• MD/PhD/PharmD with 5+ years of drug development experience, including 3 in regulatory.
• Experience leading interactions with major Health Authorities (FDA, EMA).

Responsibilities

• Develop worldwide regulatory strategies to optimize labeling and accelerate approvals.
• Lead regulatory filings and serve as global single point of contact for projects.
• Coordinate submissions with regional teams and agencies across lifecycle.
• Provide expert regulatory guidance to Product Development Teams and cross‑functional partners.
• Interact with FDA, EMA, and other agencies; lead meetings and communications.

Skills

Global regulatory strategy

Regulatory submissions

Leadership

Cross-functional collaboration

Regulatory affairs management

Strategic thinking

Excellent communication

Interaction with health authorities

Education

BS/MS in relevant field

MD/PhD/PharmD with regulatory experience

Job description

Merck in USA (Rahway) seeks a Director (Principal Scientist) for Global Regulatory Liaison to drive worldwide regulatory strategies for Immunology projects and to optimize labeling and time-to-approval with global agencies. You will manage complex programs, lead cross-functional teams, and serve as the primary global contact on regulatory issues throughout the drug life cycle.

Preferred immunology experience with a track record in leading regulatory filings, strategic thinking, and effective