Global Regulatory Lead - Immunology, Fast-Track Approvals

Merck; Rahway (NJ); Remote; USD 173,000 - 273,000; Full time

Job summary

Merck in Rahway, NJ seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects. You will coordinate global regulatory activities, liaise with FDA/EMA, and guide product labeling and approvals across lifecycle stages.

We value proactive leadership, cross-functional collaboration, and experience managing complex programs with external partners. Immunology experience is preferred and global coordination is required.

Qualifications

• Strong strategic thinking and problem-solving mindset.
• Effective written and verbal communicator across levels.
• Experience interacting with major Health Authorities (FDA/EMA).
• Expertise in leading regulatory filings across global regions.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and speed approvals.
• Assesses regulatory landscape to guide global strategies for speed-to-market.
• Acts as Global Regulatory Lead for development teams and internal/external stakeholders.
• Leads Global Regulatory Team coordinating cross-functional regulatory support.
• Coordinates IND/CTAs preparation and regulatory submissions globally.
• Reviews and approves local registration study protocols for marketing authorization.
• Interacts with regulatory agencies through meetings, teleconferences, and communications.
• Coordinates regional strategy with RA Europe and affiliates.
• Reviews Worldwide Marketing Applications, CSRs, protocols, and Investigator Brochures.
• Participates in regulatory due diligence for licensing opportunities.

Skills

Global Regulatory

Regulatory Submissions

Regulatory Strategies

Regulatory Affairs Management

Drug Development

Regulatory Processes

Regulatory Communications

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Strategic Leadership

Education

B.S./M.S in relevant field

M.D./PhD/PharmD in relevant field

Job description

Merck in Rahway, NJ seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects. You will coordinate global regulatory activities, liaise with FDA/EMA, and guide product labeling and approvals across lifecycle stages.

We value proactive leadership, cross-functional collaboration, and experience managing complex programs with external partners. Immunology experience is preferred and global coordination is required.