Global Regulatory Strategy Lead (Immunology)

Merck; Annapolis (MD); On-site; USD 191,000 - 300,000; Full time

Job summary

Merck is seeking a Senior Director, Regulatory Affairs Liaison to lead worldwide regulatory strategies for Immunology programs. You will act as the global point of contact, guiding development teams and coordinating with FDA/EMA across multiple markets.

This senior role requires strategic thinking, strong communication, and a track record of regulatory leadership, including advisory committee prep and due diligence support. Immunology experience is preferred.

Qualifications

• B.S./M.S. with a minimum of 10 years of relevant drug development experience with majority in regulatory.
• M.D. or PhD/PharmD with a minimum of 7 years relevant drug development experience with five years in regulatory.
• Strong strategic thinking, problem-solving, and continuous learning mindset.
• Experience leading interactions with major Health Authorities (FDA, EMA).
• Global regulatory affairs experience in major markets (U.S., EU, Japan, China).
• Demonstrated leadership attributes; ability to build and lead high-performing teams.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and shorten approval times.
• Leads global regulatory teams and serves as single point-of-contact for development programs.
• Interacts with regulatory agencies (FDA, EMA) and leads regulatory meetings.
• Prepares IND/CTAs for global studies and regulatory submissions.
• Oversees regulatory review of global applications and documentation.
• Guides cross-functional teams on regulatory strategy and due diligence.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Documents

Regulatory Processes

Regulatory Strategies

Regulatory Strategy Development

Regulatory Submissions

Strategic Leadership

Education

B.S./M.S. with 10+ years in regulatory-focused drug development

M.D./Ph.D./PharmD with 7+ years in regulatory

Job description

Merck is seeking a Senior Director, Regulatory Affairs Liaison to lead worldwide regulatory strategies for Immunology programs. You will act as the global point of contact, guiding development teams and coordinating with FDA/EMA across multiple markets.

This senior role requires strategic thinking, strong communication, and a track record of regulatory leadership, including advisory committee prep and due diligence support. Immunology experience is preferred.