Global Regulatory Lead, Immunology

Merck; Denver (CO); Remote; USD 191,000 - 300,000; Full time

Benefits offered by this job

Annual bonus and long-term incentive

Medical, dental, vision benefits

401(k) retirement plan

Job summary

Merck is seeking a Senior Director of Regulatory Affairs Liaison to guide worldwide regulatory strategies across immunology programs. You will act as the global point of contact and lead the regulatory team through development and lifecycle management of investigational and marketed products.

The role requires strategic thinking, strong communication, and extensive regulatory experience with major markets including the U.S., EU, and other global regions.

Qualifications

• BS/MS with 10+ years drug development experience
• MD/PhD/PharmD with 7+ years drug development, regulatory focus

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and accelerate approvals
• Leads regulatory meetings with FDA/EMA and global health authorities
• Mentors Global Regulatory Team and coordinates cross-functional support
• Manages regulatory submissions, INDs/CTAs, and regulatory due diligence

Skills

Drug Development

Global Regulatory

Regulatory Affairs Management

Regulatory Submissions

Regulatory Strategy

Strategic Leadership

Education

BS/MS in a relevant field

MD/PhD/PharmD with regulatory experience

Job description

Merck is seeking a Senior Director of Regulatory Affairs Liaison to guide worldwide regulatory strategies across immunology programs. You will act as the global point of contact and lead the regulatory team through development and lifecycle management of investigational and marketed products.

The role requires strategic thinking, strong communication, and extensive regulatory experience with major markets including the U.S., EU, and other global regions.