Global Regulatory Lead, Immunology

MSD Malaysia; Rahway, Northern (NJ, KY); Hybrid; USD 191,000 - 300,000; Full time

Job summary

Merck & Co., Inc. seeks a Senior Principal Scientist, Regulatory Liaison to lead worldwide regulatory strategies for General Medicine immunology programs. The role includes directing regulatory teams, optimizing labeling, and speeding approvals by engaging FDA/EMA and other agencies.

The ideal candidate has a strategic mindset, strong communication skills, and a track record in global regulatory affairs across major markets. Remote work options with travel up to 10% are possible.

Qualifications

• Bachelor’s or higher degree with extensive regulatory drug development experience.
• Experience leading global regulatory strategies and interactions with health authorities.
• Immunology experience preferred; global market knowledge in US/EU/Japan/China.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and speed approvals.
• Acts as global regulatory lead and single point of contact for development programs.
• Leads cross-functional teams and regulatory submissions across regions.
• Interacts with FDA/EMA and other health authorities.
• Prepares for advisory committee interactions and regulatory due diligence.

Skills

Strategic thinking

Regulatory strategy

Global regulatory

FDA/EMA experience

Leadership

Immunology

People management

Education

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

M.D./PhD/PharmD

Tools

ICH guidelines

Regulatory submissions

Job description

Merck & Co., Inc. seeks a Senior Principal Scientist, Regulatory Liaison to lead worldwide regulatory strategies for General Medicine immunology programs. The role includes directing regulatory teams, optimizing labeling, and speeding approvals by engaging FDA/EMA and other agencies.

The ideal candidate has a strategic mindset, strong communication skills, and a track record in global regulatory affairs across major markets. Remote work options with travel up to 10% are possible.