Global Regulatory Lead - Immunology Strategy

Merck; Lansing (MI); On-site; USD 191,000 - 300,000; Full time

Job summary

Merck in the United States seeks a Senior Director, Regulatory Affairs Liaison to lead worldwide regulatory strategies for General Medicine immunology programs. You will act as global regulatory lead, coordinating with FDA/EMA and product teams to optimize labeling and speed approvals across markets.

The role requires strategic thinking, senior leadership, and extensive global regulatory experience, including interactions with Health Authorities and cross-functional teams.

Qualifications

• BS/MS with minimum 10 years in drug development or regulatory
• MD/PhD/PharmD with minimum 7 years in drug development and 5 in regulatory

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and speed approvals
• Provides global regulatory leadership to Product Development Teams
• Leads regulatory submissions and communications with FDA/EMA and other agencies
• Coordinates cross-functional regulatory support for development programs and marketed products
• Reviews regulatory literature, clinical study reports, and protocols for global submissions
• Participates in regulatory due diligence for licensing candidates

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Documents

Regulatory Processes

Regulatory Strategies

Regulatory Strategy Development

Regulatory Submissions

Strategic Leadership

Education

B.S. or M.S. with minimum regulatory drug development experience

M.D. or PhD/PharmD with regulatory experience

Job description

Merck in the United States seeks a Senior Director, Regulatory Affairs Liaison to lead worldwide regulatory strategies for General Medicine immunology programs. You will act as global regulatory lead, coordinating with FDA/EMA and product teams to optimize labeling and speed approvals across markets.

The role requires strategic thinking, senior leadership, and extensive global regulatory experience, including interactions with Health Authorities and cross-functional teams.