Global Regulatory Immunology Lead - Remote

Merck; Saint Paul (MN); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Healthcare benefits

Retirement plan

Job summary

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects. You will interact with global agencies and affiliates, coordinating submissions and strategy to achieve the fastest time to approval.

The role requires maturity in regulatory affairs, strong leadership, and experience with interactions with major Health Authorities. This position offers global scope with potential for remote work arrangements and a

Qualifications

• BS/ MS with minimum 7 years of drug development experience in regulatory
• MD/PhD/ PharmD with minimum 5 years drug development experience with three years in regulatory
• Strong strategic thinking and problem-solving; effective communicator across levels
• Experience leading or supporting direct interactions with major Health Authorities (e.g., FDA, EMA)
• Demonstrated expertise in leading regulatory filings across global regions

Responsibilities

• Develop worldwide regulatory strategies to optimize labeling and accelerate approval.
• Assess regulatory/competitive landscape to guide global strategy and speed-to-market.
• Serve as global regulatory lead and single point of contact for development teams and partners.
• Provide leadership to the Global Regulatory Team coordinating cross-functional regulatory support.
• Coordinate preparation, submission and follow-up with regulatory agencies and subsidiaries.
• Review and approve local registration study protocols for marketing authorization in secondary markets.
• Interact with regulatory agencies (FDA, EMA) including meetings and written communications.
• Coordinate regional regulatory strategy through collaboration with RA Europe and local affiliates.
• Review Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures.
• Prepare IND/CTAs for global studies and participate in regulatory due diligence for licensing.
• Lead or participate in regulatory due diligence activities for licensing candidate reviews

Skills

Drug Development

Global Regulatory

Regulatory Affairs Management

Regulatory Submissions

Strategic Leadership

Education

MD/PhD/PharmD with regulatory experience

BS/MS with regulatory drug development experience

Job description

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects. You will interact with global agencies and affiliates, coordinating submissions and strategy to achieve the fastest time to approval.

The role requires maturity in regulatory affairs, strong leadership, and experience with interactions with major Health Authorities. This position offers global scope with potential for remote work arrangements and a