Global Regulatory Leader, Immunology (Remote)

Merck; Santa Fe (NM); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement plan

Paid holidays

Vacation

Job summary

Merck & Co., Inc. seeks a Director (Principal Scientist) Global Regulatory Liaison to drive worldwide regulatory strategies and oversight for Immunology indications.

You will lead cross-functional teams, coordinate global filings, and interact with major health authorities across regions to accelerate approvals. The role requires substantial regulatory leadership experience, strong strategic thinking, and a proven track record in global submissions.

Qualifications

• BS or MS with 7+ years drug development experience, regulatory focus.
• MD/PhD/PharmD with 5+ years regulatory experience.
• Experience leading interactions with Health Authorities (FDA, EMA).
• Immunology expertise preferred and global regulatory filings experience.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and approvals.
• Lead regulatory teams and be single point of contact on projects.
• Coordinate regulatory submissions and interact with agencies.
• Engage with RA Europe and local affiliates.
• Review marketing applications, protocols, and study reports.

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

B.S./M.S.

MD/PhD/PharmD

Job description

Merck & Co., Inc. seeks a Director (Principal Scientist) Global Regulatory Liaison to drive worldwide regulatory strategies and oversight for Immunology indications.

You will lead cross-functional teams, coordinate global filings, and interact with major health authorities across regions to accelerate approvals. The role requires substantial regulatory leadership experience, strong strategic thinking, and a proven track record in global submissions.