Global Regulatory Advertising and Promotion Lead

Mirum Pharmaceuticals, Inc.; Foster City (CA); On-site; USD 240,000 - 260,000; Full time

Job summary

Mirum Pharmaceuticals in Foster City, CA, seeks a Director, Global Regulatory Affairs Advertising and Promotion to provide strategic regulatory leadership for commercial materials and submissions, reporting to the Senior Director of Global Regulatory Affairs Labeling.

You will lead cross-functional teams, oversee OPDP interactions with FDA, and develop compliant promotional strategies across programs, ensuring timely, risk-aware execution.

Qualifications

• Bachelor’s or advanced degree in a scientific discipline, with a minimum of 10-12 years in Regulatory Affairs with a minimum of 10 years of experience in the regulatory review of advertising and promotional materials for prescription drug and/or biologic products
• Demonstrated experience reviewing promotional and non-promotional materials in an MLR environment
• Direct experience with the FDA’s Office of Prescription Drug Promotion (OPDP), including promotional material submissions and regulatory strategy
• Experience representing Commercial Regulatory Affairs on cross functional teams is desirable
• Experience with prescription drug labeling, including familiarity with USPI and/or global labeling documents, is preferred
• Excellent planning and organizational skills, with a demonstrated ability to independently manage multiple projects and competing priorities
• Excellent communication skills both in writing and verbally

Responsibilities

• Provide commercial regulatory leadership for assigned programs.
• Serve as a regulatory Advertising & Promotion subject-matter expert for promotional materials.
• Regulator liaison to FDA/CDER/OPDP and other health agencies as appropriate.
• Oversee regulatory submissions and coordinate with Publishing vendors for timely promotion submissions.
• Represent Commercial Regulatory Advertising and Promotion at labeling meetings.
• Provide regulatory guidance on new concepts and campaigns.
• Stay current with FDA regulations and guidance and translate to practical recommendations.
• Be recognized as an expert resource across departments.
• Contribute to process improvements for commercial regulatory activities and MLR Committee.
• Develop and implement regulatory advertising and promotional processes as needed.
• Establish and maintain tracking and planning systems for milestones and deadlines.

Skills

Project management

Communication skills

Organizational skills

Cross-functional collaboration

Education

Bachelor’s degree in a scientific discipline

Advanced degree in scientific field

Job description

Mirum Pharmaceuticals in Foster City, CA, seeks a Director, Global Regulatory Affairs Advertising and Promotion to provide strategic regulatory leadership for commercial materials and submissions, reporting to the Senior Director of Global Regulatory Affairs Labeling.

You will lead cross-functional teams, oversee OPDP interactions with FDA, and develop compliant promotional strategies across programs, ensuring timely, risk-aware execution.