Global Regulatory Lead, Immunology

Merck; Madison (WI); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement benefits

Paid holidays

Vacation

Compassionate and sick days

Job summary

Merck & Co., Inc. is seeking a Director (Principal Scientist), Global Regulatory Liaison to design and implement worldwide regulatory strategies for Immunology programs.

You will act as the single global contact on project teams, coordinating with agencies and subsidiaries to optimize labeling and speed approvals. The role demands independent project management, proactive leadership, and strong regulatory filing experience across global regions; immunology background is preferred.

Qualifications

• BS/MS with at least 7 years of drug development experience with a regulatory focus
• MD/PhD/PharmD with at least 5 years of drug development experience, including 3 years in regulatory

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and time-to-approval.
• Assesses regulatory landscapes to enable speed-to-market and targeted labeling.
• Serves as global regulatory lead to product teams and as single point-of-contact for strategies and registrations.
• Leads Global Regulatory Team and coordinates cross-functional regulatory support for programs.
• Coordinates regulatory submissions and follow-up with agencies and subsidiaries; responsible for reviews and approvals.
• Reviews local registration study protocols when needed to obtain market authorization.
• Interacts independently with regulatory agencies (FDA, EMA) including meetings and written communications.
• Coordinates regional strategy with Regulatory Affairs Europe and local affiliates.
• Reviews Worldwide Marketing Applications and Clinical Study Reports; prepares IND/CTAs for global studies.
• Participates in regulatory due diligence for licensing candidates.
• Preferred immunology expertise and experience with US/EU/Japan/China markets

Skills

Global Regulatory

Regulatory Strategy

Regulatory Affairs

Regulatory Submissions

Leadership

Communication

Education

BS/MS in related field

MD/PhD/PharmD

Job description

Merck & Co., Inc. is seeking a Director (Principal Scientist), Global Regulatory Liaison to design and implement worldwide regulatory strategies for Immunology programs.

You will act as the single global contact on project teams, coordinating with agencies and subsidiaries to optimize labeling and speed approvals. The role demands independent project management, proactive leadership, and strong regulatory filing experience across global regions; immunology background is preferred.