Immunology Global Regulatory Scientist Lead

HireLifeScience; Upper Gwynedd Township (Montgomery County); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Remote work arrangement

Job summary

Merck & Co. in the United States seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies across the Immunology portfolio.

You will serve as the global point of contact for development programs and work with FDA, EMA, and other authorities to accelerate approvals and optimize labeling. You will manage cross-functional teams, supervise regulatory submissions, and guide programs through lifecycle from development to marketed products.

Qualifications

• BS/MS with at least 7 years in drug development/regulatory
• MD/PhD/PharmD with at least 5 years in drug development and 3 in regulatory
• Strong strategic thinking and problem-solving
• Excellent written and verbal communication and ability to influence across levels
• Experience interacting with major Health Authorities (FDA/EMA)
• Experience leading global regulatory filings

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and shorten time to approval
• Leads the Global Regulatory Team coordinating cross-functional regulatory support
• Coordinates submissions and communications with regulatory agencies
• Reviews study protocols and local registrations for marketing authorization
• Interacts with FDA/EMA and other agencies on regulatory matters

Skills

Regulatory strategy

Global regulatory lead

Leadership

Regulatory submissions

FDA interactions

EMA interactions

Immunology

Regulatory affairs

Education

BS/MS 7+ years

MD/PhD/PharmD 5+ years

Job description

Merck & Co. in the United States seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies across the Immunology portfolio.

You will serve as the global point of contact for development programs and work with FDA, EMA, and other authorities to accelerate approvals and optimize labeling. You will manage cross-functional teams, supervise regulatory submissions, and guide programs through lifecycle from development to marketed products.