Global Immunology Regulatory Lead (Remote)

MSD; United States; Remote; USD 170,000 - 230,000; Full time

Job summary

Merck & Co., Inc. is seeking a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs and to optimize labeling for fastest possible approvals.

The position reports to the Executive Director, General Medicine and requires proactive leadership across global teams. The role entails independent project management, interaction with global health authorities, and coordination of submissions across indications, products and life-cycle

Qualifications

• BS or MS with substantial drug development experience in regulatory.
• MD/PhD/PharmD with regulatory focus and 5+ years in the field.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and approvals.
• Interacts with FDA, EMA and other agencies on regulatory matters.
• Leads regulatory filings across global regions and life cycle management.
• Coordinates cross-functional regulatory support for development programs and marketed products.
• Reviews and approves study protocols for marketing authorization in secondary markets.
• Prepares IND/CTAs for global studies and regulatory submissions.
• Participates in regulatory due diligence activities for licensing reviews.

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

BS/MS degree in a scientific discipline

MD/PhD/PharmD with regulatory experience

Job description

Merck & Co., Inc. is seeking a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs and to optimize labeling for fastest possible approvals.

The position reports to the Executive Director, General Medicine and requires proactive leadership across global teams. The role entails independent project management, interaction with global health authorities, and coordination of submissions across indications, products and life-cycle