Remote Global Regulatory Lead, Immunology

Merck; Salem (OR); Remote; USD 191,000 - 300,000; Full time

Job summary

Merck in the United States is seeking a Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison to lead worldwide regulatory strategies for General Medicine immunology programs and to act as the single global contact on project teams.

The role involves interacting with FDA/EMA, leading cross-functional regulatory efforts, preparing submissions, and guiding product labeling to accelerate approvals, with about 10% travel and a comprehensive benefits package.

Qualifications

• Strong regulatory strategy experience across global regions.
• Experience interacting with major Health Authorities (FDA/EMA).
• Proven leadership of cross-functional regulatory teams.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and approvals.
• Interacts with regulatory agencies and leads regulatory meetings.
• Prepares INDs/CTAs and manages regulatory submissions across programs.
• Leads cross-functional teams for development programs and marketed products.

Skills

Regulatory Strategy

FDA/EMA interactions

Leadership

Cross-functional collaboration

Immunology experience

Education

Bachelor's/Master's in relevant field

MD/PhD/PharmD preferred

Tools

Global regulatory submissions tools

Job description

Merck in the United States is seeking a Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison to lead worldwide regulatory strategies for General Medicine immunology programs and to act as the single global contact on project teams.

The role involves interacting with FDA/EMA, leading cross-functional regulatory efforts, preparing submissions, and guiding product labeling to accelerate approvals, with about 10% travel and a comprehensive benefits package.