Global Regulatory Liaison Director, Immunology, Remote

Merck; Boise (ID); Remote; USD 173,000 - 273,000; Full time

Job summary

Merck, Rahway, USA, seeks a Director, Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs. The role oversees regulatory plans, interacts with major authorities, and guides cross‑functional teams through submissions and labeling decisions.

The candidate should bring senior leadership experience, a track record of global filings, and immunology regulatory expertise. The position allows remote work with an emphasis on collaboration across regions.

Qualifications

• BS or MS with 7+ years in drug development, regulatory focus.
• MD/PhD/PharmD with 5+ years in regulatory, 3+ in leadership.
• Proven ability to lead regulatory filings and interactions with Health Authorities.
• Strong strategic, communication and negotiation skills.

Responsibilities

• Develop worldwide regulatory strategies to optimize labeling and approval timelines.
• Assess regulatory/competitive landscape to guide global strategy.
• Lead regulatory teams and serve as global point of contact for projects.
• Coordinate submissions and interactions with FDA, EMA, and others.
• Review and approve study protocols for global regulatory clearance.
• Lead or support high-stakes regulatory meetings and due diligence.

Skills

Global Regulatory

Regulatory Strategy

Regulatory Submissions

Senior Leadership

Cross-functional Collaboration

Education

BS/MS in life sciences

MD/PhD/PharmD with regulatory exp

Job description

Merck, Rahway, USA, seeks a Director, Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs. The role oversees regulatory plans, interacts with major authorities, and guides cross‑functional teams through submissions and labeling decisions.

The candidate should bring senior leadership experience, a track record of global filings, and immunology regulatory expertise. The position allows remote work with an emphasis on collaboration across regions.