Global Regulatory Lead, Immunology - Remote Strategy

Merck; Richmond (VA); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical insurance

Dental & Vision benefits

401(k) retirement plan

Paid holidays and vacation

Job summary

Merck & Co., Inc. seeks a Director (Principal Scientist), Global Regulatory Liaison to shape worldwide regulatory strategies for Immunology programs, optimizing labeling and timing of approvals.

You will lead a global regulatory team, coordinate submissions with FDA/EMA, interact with agencies, and align regional plans with affiliates, ensuring efficient lifecycle management of investigational and marketed products.

Qualifications

• B.S. or M.S with a minimum of 7 years of relevant drug development experience with regulatory focus.
• M.D. or PhD/PharmD with a minimum of 5 years relevant drug development experience with three years in regulatory.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and speed approvals by agencies.
• Assesses regulatory/competitive landscape to guide global strategies for speed-to-market.
• Lead regulatory teams; act as global point-of-contact for development programs and partners.
• Coordinate regulatory submissions and interactions with agencies and affiliates.
• Prepare IND/CTAs and oversee lifecycle regulatory activities across regions.
• Interact with FDA, EMA and other authorities; lead regulatory meetings and communications.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Leadership

Education

B.S./M.S. degree

M.D./PhD/PharmD

Job description

Merck & Co., Inc. seeks a Director (Principal Scientist), Global Regulatory Liaison to shape worldwide regulatory strategies for Immunology programs, optimizing labeling and timing of approvals.

You will lead a global regulatory team, coordinate submissions with FDA/EMA, interact with agencies, and align regional plans with affiliates, ensuring efficient lifecycle management of investigational and marketed products.