Global Regulatory Lead, Immunology (Remote)

Merck; Santa Fe (NM); Remote; USD 173,000 - 273,000; Full time

Job summary

Merck in Rahway, NJ seeks a Director (Principal Scientist), Global Regulatory Liaison to develop worldwide regulatory strategies for Immunology programs and optimize labeling to shorten time to approval. The person leads global teams, serves as single point of contact with health authorities, coordinates filings, and collaborates across product development to ensure successful regulatory outcomes.

Strong leadership, experience with FDA/EMA, and immunology expertise are preferred; US relocation

Qualifications

• 7+ years of relevant drug development experience with majority in regulatory
• MD/PhD/PharmD with 5+ years regulatory experience, including leadership roles

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and speed approvals
• Leads regulatory filings and interactions with FDA, EMA, and other agencies
• Acts as global single point of contact for regulatory issues across development stages
• Coordinates cross-functional regulatory support for development programs and marketed products
• Partners with regional teams to align submissions and maintain lifecycle regulatory plans

Skills

Strategic thinking

Communication skills

Regulatory leadership

Cross-functional collaboration

Education

BS/MS in drug development or related field

MD/PhD/PharmD with regulatory experience

Job description

Merck in Rahway, NJ seeks a Director (Principal Scientist), Global Regulatory Liaison to develop worldwide regulatory strategies for Immunology programs and optimize labeling to shorten time to approval. The person leads global teams, serves as single point of contact with health authorities, coordinates filings, and collaborates across product development to ensure successful regulatory outcomes.

Strong leadership, experience with FDA/EMA, and immunology expertise are preferred; US relocation