Remote Global Regulatory Strategist (Immunology)

Merck; Helena (MT); Remote; USD 173,000 - 273,000; Full time

Job summary

Merck & Co., Inc. seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects.

You will optimize labeling and shorten time to approval by global agencies, acting as the single global contact for development programs. You will interact with FDA/EMA, coordinate regional submissions, and guide cross-functional teams through the life cycle of drug development.

Qualifications

• Bachelor's or higher degree with strong regulatory background.
• Experience leading global regulatory filings across regions.
• Proven ability to interact with major Health Authorities (FDA, EMA).
• Strategic thinking and effective cross-functional leadership.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and approval timelines.
• Coordinates global regulatory submissions with internal teams and affiliates.
• Leads regulatory teams and serves as the single global point of contact.
• Engages with health authorities and external partners to advance programs.
• Reviews marketing applications and clinical study documents for filings.
• Oversees regulatory due diligence for licensing and collaborations.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Regulatory Affairs Management

Regulatory Submissions

Strategic Leadership

Education

B.S. or M.S. in a related field

M.D. or PhD/PharmD with regulatory experience

Job description

Merck & Co., Inc. seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects.

You will optimize labeling and shorten time to approval by global agencies, acting as the single global contact for development programs. You will interact with FDA/EMA, coordinate regional submissions, and guide cross-functional teams through the life cycle of drug development.