Global Regulatory Strategy Director - Remote

Merck; Honolulu (HI); À distance; USD 173 000 - 273 000; Plein temps

Résumé du poste

Merck seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies in Immunology. You will optimize labeling, coordinate global submissions, and serve as the global regulatory contact for multiple programs.

The role requires senior leadership, proactive management of complex programs, and strong interaction with major health authorities. Location: Rahway, NJ or remote with travel.

Qualifications

• Strong strategic thinking and problem-solving abilities.
• Experience with leading interactions with major Health Authorities (FDA/EMA).
• Proven track record in global regulatory filings across regions.

Responsabilités

• Develops worldwide regulatory strategies to optimize labeling and approval timelines.
• Acts as global regulatory lead and single point of contact for project teams.
• Coordinates submissions and regulatory interactions across regions.

Connaissances

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Leadership

Formation

B.S. or M.S with regulatory experience

M.D. or PhD/PharmD with regulatory focus

Description du poste

Merck seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies in Immunology. You will optimize labeling, coordinate global submissions, and serve as the global regulatory contact for multiple programs.

The role requires senior leadership, proactive management of complex programs, and strong interaction with major health authorities. Location: Rahway, NJ or remote with travel.