Global Regulatory Lead, Immunology — Remote

Merck; Boston (MA); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Remote work

Comprehensive benefits

Job summary

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to drive worldwide regulatory strategies across Immunology programs. This role reports to the Executive Director, General Medicine and serves as the global lead for regulatory strategy, labeling optimization, and time-to-approval targets.

Lead cross-functional teams and interact with major health authorities to advance investigational and marketed products throughout their lifecycles.

Qualifications

• B.S. or M.S with a minimum of 7 years in drug development with major regulatory exposure.
• M.D./Ph.D./PharmD with a minimum of 5 years drug development experience and at least 3 years in regulatory.
• Experience leading interactions with major Health Authorities (FDA, EMA).

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and speed approvals.
• Provides regulatory leadership to Product Development Teams and acts as global single point of contact.
• Leads cross-functional Regulatory support and coordinates with regional affiliates and agencies.
• Reviews regulatory submissions, study protocols, and investigator brochures for regulatory readiness.
• Reviews and finalizes local registration study protocols for marketing authorization in secondary markets.

Job description

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to drive worldwide regulatory strategies across Immunology programs. This role reports to the Executive Director, General Medicine and serves as the global lead for regulatory strategy, labeling optimization, and time-to-approval targets.

Lead cross-functional teams and interact with major health authorities to advance investigational and marketed products throughout their lifecycles.