Immunology Regulatory Strategy Director (Remote)

Merck; Hartford (CT); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Retirement benefits (401(k))

Paid holidays

Vacation

Sick days

Job summary

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to develop and implement worldwide regulatory strategies across their Immunology portfolio. This role oversees regulatory activities to optimize labeling and accelerate approvals, acting as the global point of contact for development programs and marketed drugs/biologics.

The position requires leadership of cross-functional teams, engagement with major health authorities, and experience in immunology preferred.

Qualifications

• Strong strategic thinking and problem-solving mindset.
• Experience leading interactions with major Health Authorities (FDA, EMA).
• Expertise in regulatory filings across global regions.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and approval timelines.
• Assesses regulatory landscape to speed time-to-market and guide labeling.
• Acts as global regulatory lead on product teams, cross-functional liaison.
• Leads Global Regulatory Team coordinating cross-functional regulatory support.
• Coordinates preparation, submission and follow-up with regulatory agencies.
• Reviews study protocols for marketing authorization in secondary markets.
• Interacts independently with regulatory agencies (FDA, EMA) and leads meetings.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Regulatory Affairs Management

Regulatory Submissions

Strategic Leadership

Effective Communicator

Education

B.S./M.S. with 7+ years regulatory drug development experience

M.D. or PhD/PharmD with 5+ years regulatory experience

Job description

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to develop and implement worldwide regulatory strategies across their Immunology portfolio. This role oversees regulatory activities to optimize labeling and accelerate approvals, acting as the global point of contact for development programs and marketed drugs/biologics.

The position requires leadership of cross-functional teams, engagement with major health authorities, and experience in immunology preferred.