Global Regulatory Lead, Immunology (Remote)

Merck; Montpelier (VT); Remote; USD 191,000 - 300,000; Full time

Job summary

Merck & Co., Inc. seeks a Senior Director (Sr. Principal Scientist) Regulatory Affairs Liaison to lead worldwide regulatory strategies for General Medicine with a focus on Immunology.

The role acts as the global single point of contact on projects, guiding labeling and strategic regulatory decisions across markets. They will interact with Worldwide Regulatory Agencies, lead regulatory meetings, and coordinate cross-functional teams to accelerate time-to-approval while maintaining compliance.

Qualifications

• Bachelor’s or Master’s degree with substantial regulatory drug development experience.
• MD/PhD/PharmD plus regulatory leadership experience.
• Experience interacting with major Health Authorities (FDA/EMA) preferred.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and speed approvals.
• Leads regulatory meetings with FDA/EMA and other agencies.
• Manages global regulatory submissions and documentation across multiple markets.
• Provides expert regulatory advice as Global Regulatory Lead to Product Development Teams.
• Leads cross-functional regulatory support for development programs and marketed products.
• Coordinates preparation and follow-up with regulatory agencies throughout product life cycle.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Documents

Regulatory Processes

Regulatory Strategies

Regulatory Strategy Development

Regulatory Submissions

Strategic Leadership

Education

B.S. or M.S with minimum 10 years drug development regulatory

M.D. or PhD/PharmD with minimum 7 years regulatory

Job description

Merck & Co., Inc. seeks a Senior Director (Sr. Principal Scientist) Regulatory Affairs Liaison to lead worldwide regulatory strategies for General Medicine with a focus on Immunology.

The role acts as the global single point of contact on projects, guiding labeling and strategic regulatory decisions across markets. They will interact with Worldwide Regulatory Agencies, lead regulatory meetings, and coordinate cross-functional teams to accelerate time-to-approval while maintaining compliance.