Global Regulatory Liaison Scientist (Hybrid)

MSD; Rahway (NJ); Hybrid; USD 173,000 - 273,000; Full time

Job summary

Merck & Co. in the United States seeks a Global Regulatory Liaison to develop and implement worldwide regulatory strategy for oncology, immunology and devices programs.

You will coordinate with FDA, EMA and international teams to shorten time to approval while ensuring regulatory compliance across markets. You will lead the Global Regulatory Team, review submissions, and provide strategic direction to Product Development Teams.

Qualifications

• Extensive regulatory affairs experience across drug development life cycle.
• Proven ability to lead cross-functional teams and influence regulators.
• Experience interacting with FDA, EMA or other Health Authorities.

Responsibilities

• Develops worldwide regulatory strategy to optimize labeling and approvals.
• Leads Global Regulatory Team coordinating cross-functional support.
• Reviews and approves local/global submission documents and studies.
• Represents company with regulators and external stakeholders.
• Supports advisory committees and regulatory due diligence.

Skills

Clinical Research

Cross-Functional Teamwork

Drug Development

Global Regulatory

Oncology

Regulatory Affairs Management

Regulatory Communications

Regulatory Documents

Regulatory Filings

Regulatory Management

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Planning

Strategic Thinking

Education

B.S. Degree in biological science or related

M.S. with 10+ years experience

PhD with 7+ years relevant experience

M.D. with 5+ years relevant experience

Job description

Merck & Co. in the United States seeks a Global Regulatory Liaison to develop and implement worldwide regulatory strategy for oncology, immunology and devices programs.

You will coordinate with FDA, EMA and international teams to shorten time to approval while ensuring regulatory compliance across markets. You will lead the Global Regulatory Team, review submissions, and provide strategic direction to Product Development Teams.