Global Regulatory Lead - Immunology (Remote)

Merck; Salem (OR); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical insurance

401(k) plan

Job summary

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to develop and implement worldwide regulatory strategies for Immunology projects. You will lead regulatory oversight, optimize labeling, and drive fastest time to approval with global agencies.

The role requires strong leadership, proactive program management, and extensive experience in regulatory filings across multiple regions. Immunology expertise is preferred, with remote flexibility and a comprehensive benefits

Qualifications

• Minimum of 7 years of relevant drug development experience with majority in regulatory.
• Minimum of 5 years relevant drug development experience with three years in regulatory.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and time to approval.
• Coordinates regulatory submissions and serves as global single point of contact for projects.
• Leads cross-functional regulatory teams and interactions with health authorities.
• Reviews regulatory documents and ensures compliance across regions.
• Prepares IND/CTAs and supports regulatory due diligence.

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

Bachelor's or Master’s degree

M.D. or Ph.D./PharmD

Job description

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to develop and implement worldwide regulatory strategies for Immunology projects. You will lead regulatory oversight, optimize labeling, and drive fastest time to approval with global agencies.

The role requires strong leadership, proactive program management, and extensive experience in regulatory filings across multiple regions. Immunology expertise is preferred, with remote flexibility and a comprehensive benefits