Remote Global Regulatory Lead, Immunology

Merck; Des Moines (IA); Remote; USD 191,000 - 300,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Job summary

Merck is seeking a Sr. Director, Regulatory Affairs Liaison to lead global regulatory strategies for Immunology programs and act as the worldwide regulatory lead across development and lifecycle stages.

You will interact with FDA, EMA and other authorities, guiding labeling optimization and submission strategies. The role requires strong leadership, strategic thinking, and a track record in global regulatory affairs across major markets.

Qualifications

• B.S. or M.S. with 10+ years in drug development, majority in regulatory.
• M.D. or PhD/PharmD with 7+ years relevant drug development experience, 5 in regulatory.
• Strong strategic thinking, problem-solving and continuous learning mindset.
• Effective communicator with influence, leadership and negotiation skills.
• Experience engaging with major Health Authorities (FDA, EMA).
• Global regulatory affairs experience in US, EU, Japan, China.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and speed approvals.
• Leads regulatory meetings and communications with agencies (FDA/EMA) for projects.
• Coordinates global regulatory submissions and documentation across programs.
• Provides expert regulatory guidance to product development teams.
• Leads cross-functional Global Regulatory Team to support programs.
• Reviews study protocols and registries for regulatory readiness.
• Interacts with agencies and supports FDA advisory committee prep.
• Manages multiple indications, formulations, or external partnerships.

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. or M.S. in a relevant field

M.D. or PhD/PharmD

Job description

Merck is seeking a Sr. Director, Regulatory Affairs Liaison to lead global regulatory strategies for Immunology programs and act as the worldwide regulatory lead across development and lifecycle stages.

You will interact with FDA, EMA and other authorities, guiding labeling optimization and submission strategies. The role requires strong leadership, strategic thinking, and a track record in global regulatory affairs across major markets.