Global Immunology Regulatory Lead - Principal Scientist

MSD Malaysia; North Wales (Montgomery County); On-site; USD 173,000 - 273,000; Full time

Job summary

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to design and implement worldwide regulatory strategies for Immunology programs. You will be the sole global contact, coordinating with FDA/EMA and regional affiliates to optimize labeling and speed approvals.

The role requires proactive leadership, strong communication, and extensive experience in regulatory affairs across multiple indications and external partners. Immunology background preferred.

Qualifications

• B.S./M.S. in a relevant field with extensive drug development experience.
• MD/PhD/PharmD with substantial regulatory expertise and leadership in global submissions.
• Experience interacting with major Health Authorities (FDA, EMA) and leading global filings.

Responsibilities

• Develops and executes worldwide regulatory strategies to optimize labeling and accelerate approvals.
• Advises Product Development Teams as Global Regulatory Lead across life-cycle regulatory needs.
• Leads cross-functional Global Regulatory Team and coordinates regulatory support for development programs and marketed products.
• Coordinates preparation, submission and follow-up with regulatory agencies and subsidiaries.
• Reviews study protocols and supports regulatory review and marketing authorization in secondary markets.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Leadership

Immunology

Education

B.S./M.S. in a relevant field

M.D./PhD/PharmD in a relevant field

Job description

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to design and implement worldwide regulatory strategies for Immunology programs. You will be the sole global contact, coordinating with FDA/EMA and regional affiliates to optimize labeling and speed approvals.

The role requires proactive leadership, strong communication, and extensive experience in regulatory affairs across multiple indications and external partners. Immunology background preferred.