Global Regulatory Lead — Immunology Scientist

Merck; Cheyenne (WY); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays

Vacation

Sick days

Job summary

Merck 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 global regulatory lead for development teams and liaising with agencies and subsidiaries across the product lifecycle.

The role requires proactive leadership, cross-functional coordination, and strong experience in regulatory filings across global regions, with preference

Qualifications

• BS or MS with minimum 7 years in drug development, regulatory focus.
• MD/PhD/PharmD with minimum 5 years drug development experience, regulatory focus (3 years in regulatory).
• Experience leading regulatory filings across global regions.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and time-to-approval.
• Acts as global regulatory lead and single point of contact for project teams.
• Leads cross-functional regulatory support for development programs and marketed products.
• Coordinates submissions with regulatory agencies and subsidiaries.
• Reviews and approves local registration study protocols for marketing authorization in secondary markets.
• Interacts with regulatory agencies (FDA, EMA) and leads meetings.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Leadership

Education

Bachelor’s/Master’s in relevant field

MD/PhD/PharmD with regulatory experience

Job description

Merck 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 global regulatory lead for development teams and liaising with agencies and subsidiaries across the product lifecycle.

The role requires proactive leadership, cross-functional coordination, and strong experience in regulatory filings across global regions, with preference