Global Regulatory Lead, Immunology (Remote)

Merck; Austin (TX); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical Benefits

401(k) Retirement

Job summary

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

The role leads global regulatory efforts, interfaces with health authorities, and guides labeling optimization to shorten time-to-approval. The successful candidate will manage complex regulatory programs, coordinate with global affiliates, and drive strategic submissions across multiple indications with a focus on immunology.

Qualifications

• Minimum education and experience as stated, including regulatory leadership.
• Experience interacting with major Health Authorities (FDA, EMA).
• Strong strategic thinking, problem-solving, and learning mindset.
• Excellent written and verbal communication across levels and functions.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and accelerate approvals.
• Leads cross-functional regulatory teams and coordinates agency interactions.
• Manages global regulatory submissions and follow-up with agencies.
• Reviews study protocols for marketing authorization in secondary markets.
• Interacts with FDA, EMA and other agencies to lead meetings and communications.
• Coordinates regional regulatory strategy with RA Europe and affiliates.
• Oversees reviews of Worldwide Marketing Applications, CSRs, protocols and Investigators Brochures.
• Prepares IND/CTAs for global studies.

Skills

Global Regulatory

Regulatory Strategy

Drug Development

Regulatory Submissions

Leadership

Communication

Education

B.S. or M.S. with 7+ years in drug development (regulatory focus)

M.D./Ph.D./PharmD with 5+ years regulatory experience

Job description

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

The role leads global regulatory efforts, interfaces with health authorities, and guides labeling optimization to shorten time-to-approval. The successful candidate will manage complex regulatory programs, coordinate with global affiliates, and drive strategic submissions across multiple indications with a focus on immunology.