Global Regulatory Lead, Immunology – Remote

Merck; Phoenix (AZ); Remote; USD 191,000 - 300,000; Full time

Job summary

Merck seeks a Senior Director (Sr. Principal Scientist) Regulatory Affairs Liaison to develop worldwide regulatory strategies for General Medicine, with a focus on immunology.

You will lead global regulatory activities, interact with agencies, and guide cross-functional teams to optimize labeling and speed approvals. The role requires a strategic leader with strong communication skills and extensive regulatory experience across major markets.

Qualifications

• BS or MS with 10+ years in drug development focused on regulatory or related areas.
• MD/PhD/PharmD with 7+ regulatory years and five years in regulatory roles.
• Strong strategic thinker with leadership and influencing across levels.

Responsibilities

• Develops worldwide regulatory strategies to speed approvals.
• Acts as global regulatory lead for development programs.
• Interacts with FDA/EMA and other agencies; leads regulatory meetings.
• Guides cross-functional teams through product lifecycle.

Skills

Drug Development

Global Regulatory

Pharma Industry

Pharma Research

Product Registrations

Regulatory Affairs

Regulatory Communications

Regulatory Documents

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Leadership

Education

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

M.D. or PhD/PharmD with regulatory experience

Job description

Merck seeks a Senior Director (Sr. Principal Scientist) Regulatory Affairs Liaison to develop worldwide regulatory strategies for General Medicine, with a focus on immunology.

You will lead global regulatory activities, interact with agencies, and guide cross-functional teams to optimize labeling and speed approvals. The role requires a strategic leader with strong communication skills and extensive regulatory experience across major markets.