Global Regulatory Strategy Director - Remote

Merck; Carson City (NV); Remote; USD 173,000 - 273,000; Full time

Job summary

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to drive worldwide regulatory strategies for Immunology programs and oversee regulatory activities across the product life cycle.

The role requires leadership in cross-functional teams, extensive interaction with regulators such as FDA/EMA, and a proven track record in global filings and labeling optimization. A strong immunology background is preferred.

Qualifications

• Strong strategic thinking and problem-solving abilities.
• Effective written and verbal communication with the ability to influence and negotiate across levels.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and shorten time to approval by agencies.
• Coordinat es global regulatory activities and ensures timely submissions and regulatory review.
• Lead or support regulatory interactions with major Health Authorities (FDA, EMA) and regulators.
• Provide leadership to the Global Regulatory Team coordinating cross-functional support.
• Review and approve regulatory study protocols for marketing authorization.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Leadership

Immunology

Education

B.S. or M.S with a minimum of 7 years of relevant drug development experience

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

Job description

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to drive worldwide regulatory strategies for Immunology programs and oversee regulatory activities across the product life cycle.

The role requires leadership in cross-functional teams, extensive interaction with regulators such as FDA/EMA, and a proven track record in global filings and labeling optimization. A strong immunology background is preferred.