Immunology Global Regulatory Lead

Merck; Charleston (WV); Remote; USD 173,000 - 273,000; Full time

Job summary

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects. The role requires independent project management, global regulatory contacts, and leadership of cross-functional teams to ensure optimal labeling and fastest possible approvals.

Preferred immunology background with experience across regions and both investigational and marketed products. Remote-friendly with international regulatory collaboration.

Qualifications

• Minimum education: B.S./M.S. with 7+ years in drug development; or M.D./PhD/PharmD with 5+ years with regulatory focus.

Responsibilities

• Develop worldwide regulatory strategies to optimize labeling and time to approval.
• Lead regulatory filings and interact with major health authorities (FDA, EMA).
• Coordinate cross-functional regulatory support and external partner activities throughout product life cycle.

Job description

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects. The role requires independent project management, global regulatory contacts, and leadership of cross-functional teams to ensure optimal labeling and fastest possible approvals.

Preferred immunology background with experience across regions and both investigational and marketed products. Remote-friendly with international regulatory collaboration.