Global Regulatory Lead – Oncology/Immunology Strategy

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

Job summary

Merck in Rahway, NJ seeks a seasoned Global Regulatory Liaison to drive worldwide regulatory strategy for oncology, immunology, and devices. You will oversee regulatory submissions and coordinate with global agencies to shorten time to approval, while guiding cross‑functional teams.

You will interact with FDA/other authorities, lead regulatory teams, and ensure compliant, timely filings across indications and markets. Requires extensive regulatory experience and leadership.

Qualifications

• Minimum 10 years drug development or regulatory affairs experience.
• Ability to think strategically and learn and apply new knowledge.
• Experience leading regulatory meetings with Health Authorities (FDA/EMA).

Responsibilities

• Develop worldwide regulatory strategy to optimize label and approval timelines.
• Provide expert regulatory advice to Product Development Teams and subsidiaries.
• Lead Global Regulatory Team coordinating cross-functional regulatory support.
• Review and approve local registration study protocols for marketing authorization.
• Represent the company with FDA and other health authorities; chair meetings.
• Lead cross-functional efforts for advisory committee preparation.
• Coordinate interactions with foreign agencies via Regulatory Affairs Europe.
• Review and approve Worldwide Marketing Applications, CSRs, protocols, and Investigator Brochures.

Skills

Clinical Research

Cross-Functional Teamwork

Drug Development

Global Regulatory

Oncology

Regulatory Affairs Management

Regulatory Communications

Regulatory Submissions

Strategic Planning

Strategic Thinking

Education

Bachelor's degree in biological science, chemistry or related

Master's degree (M.S.) in relevant field

PhD in relevant area

Medical Doctor (M.D.) with relevant experience

Job description

Merck in Rahway, NJ seeks a seasoned Global Regulatory Liaison to drive worldwide regulatory strategy for oncology, immunology, and devices. You will oversee regulatory submissions and coordinate with global agencies to shorten time to approval, while guiding cross‑functional teams.

You will interact with FDA/other authorities, lead regulatory teams, and ensure compliant, timely filings across indications and markets. Requires extensive regulatory experience and leadership.