Global Immunology Regulatory Lead — Remote

MSD Malaysia; Boston, Northern (MA, KY); Hybrid; USD 173,000 - 273,000; Full time

Benefits offered by this job

Competitive bonus eligibility

Comprehensive benefits package

Job summary

Merck & Co., Inc. in Rahway, NJ, USA, seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects, drive rapid approvals, and serve as the single global point of contact on regulatory issues across development programs.

You will coordinate with FDA, EMA and international agencies, oversee submissions, mentor a regulatory team, and collaborate with product development teams to optimize labeling and lifecycle regulatory plans.

Qualifications

• BS/MS in a science field with 7+ years in regulatory drug development or an MD/PhD/PharmD with 5+ years in regulatory.
• Experience leading regulatory filings across global regions (FDA, EMA, etc.).
• Strong strategic thinking, negotiation, and cross-functional collaboration skills.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and speed approvals.
• Coordinates submissions and follow-up with global regulatory agencies and affiliates.
• Leads the Global Regulatory Team and serves as the global regulatory contact for development programs.
• Interacts with FDA, EMA and other authorities; leads or participates in agency meetings and teleconferences.
• Reviews and approves regulatory documentation including CTAs/INDs and marketing applications.

Skills

Regulatory Strategy

Regulatory Submissions

Global Regulatory

Drug Development

Strategic Leadership

Regulatory Communications

Education

BS or MS in a relevant field

MD/PhD/PharmD with regulatory experience

Job description

Merck & Co., Inc. in Rahway, NJ, USA, seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects, drive rapid approvals, and serve as the single global point of contact on regulatory issues across development programs.

You will coordinate with FDA, EMA and international agencies, oversee submissions, mentor a regulatory team, and collaborate with product development teams to optimize labeling and lifecycle regulatory plans.