Global Regulatory Advertising & Promotion Director

Regulatory Jobs; Foster City (CA); Hybrid; USD 240,000 - 260,000; Full time

Job summary

Mirum Pharmaceuticals is seeking a Director of Global Regulatory Affairs Advertising and Promotion to lead strategic and operational regulatory work for commercial materials. You will partner with MLR and senior leadership to ensure compliant, timely submissions and promotion strategies for rare-disease therapies.

The role requires extensive experience with OPDP submissions, labeling knowledge, and strong cross-functional leadership.

Qualifications

• Minimum 10–12 years in Regulatory Affairs with at least 10 years in regulatory review of advertising and promotional materials for prescription drugs or biologics.
• Demonstrated experience with FDA OPDP submissions and regulatory strategy.
• Experience on cross-functional teams and in an MLR environment.
• Knowledge of US labeling and USPI considerations preferred.

Responsibilities

• Provide commercial regulatory leadership for assigned programs.
• Serve as regulatory advertising & promotion SME for materials.
• Liaise with FDA/CDER/OPDP and other health agencies as appropriate.
• Oversee or author commercial regulatory submissions and coordinate with publishing vendors.
• Represent Commercial Regulatory Advertising and Promotion at labeling meetings and provide strategic guidance.
• Provide regulatory guidance on new concepts and campaigns.
• Maintain current knowledge of FDA regulations and translate into actionable plans.
• Be a recognized expert resource across departments.
• Contribute to process improvements and the MLR Committee as needed.
• Develop and implement regulatory advertising and promotional processes.

Skills

Regulatory leadership

Communication skills

Project management

Cross-functional collaboration

OPDP knowledge

Education

Bachelor's or advanced degree in a scientific discipline

Job description

Mirum Pharmaceuticals is seeking a Director of Global Regulatory Affairs Advertising and Promotion to lead strategic and operational regulatory work for commercial materials. You will partner with MLR and senior leadership to ensure compliant, timely submissions and promotion strategies for rare-disease therapies.

The role requires extensive experience with OPDP submissions, labeling knowledge, and strong cross-functional leadership.