SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Mirum Pharmaceuticals, a biopharmaceutical company focused on rare disease treatments, seeks a Director of Global Regulatory Affairs for Advertising & Promotion. This strategic leadership role oversees all commercial regulatory activities, ensuring compliance and timely execution of business objectives.
The Director will serve as the primary regulatory expert for advertising and promotional materials, providing guidance on preparation, review, approval, and submission of commercial materials. Key responsibilities include:
• Lead commercial regulatory strategy for assigned programs and serve as subject-matter expert on advertising/promotional compliance
• Act as regulatory liaison to the FDA's Office of Prescription Drug Promotion (OPDP) and other health agencies
• Oversee or author commercial regulatory submissions and coordinate with publishing vendors for timely OPDP submissions
• Represent Commercial Regulatory at cross-functional labeling meetings and provide strategic guidance on new concepts and campaigns
• Maintain current knowledge of FDA regulations, guidance documents, enforcement actions, and regulatory precedents
• Develop and implement regulatory advertising and promotional processes
• Establish tracking and planning systems for materials under review, deliverables, submissions, milestones, and dependencies
• Contribute to process improvements within the Medical, Legal & Regulatory (MLR) Committee
The role requires 10–12 years of regulatory affairs experience, with a minimum of 10 years specifically reviewing advertising and promotional materials for prescription drugs and biologics. Direct OPDP experience is essential. Candidates should have demonstrated expertise in MLR environments, prescription drug labeling (USPI), and global regulatory requirements. Strong project management, communication, negotiation, and stakeholder engagement skills are required. The individual will work with high independence, proactively identifying and resolving issues while escalating novel or precedent-setting matters to senior leadership. Reports to the Senior Director, Global Regulatory Affairs Labeling.
