Director, Global Regulatory Affairs Advertising & Promotion

MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.

The Director, Global Regulatory Affairs Advertising and Promotion provides strategic and operational regulatory leadership for all commercial regulatory activities, enabling the business to meet its commercial objectives in a compliant and timely manner. This position will provide leadership as a key member of the Medical, Legal and Regulatory (MLR) and provides experienced regulatory guidance for the preparation, review, approval, and submission of advertising and promotional materials..

The individual is expected to work with a high degree of independence, accountability, reliability, and follow-through; proactively identify and resolve issues; anticipate risks to timelines or execution; and drive assigned activities to completion with limited day-to-day supervision. Significant, novel, or precedent-setting matters should be escalated to senior Regulatory leadership, including a clear assessment of the issue, regulatory implications and risk, available options, and a recommended approach.

This role will report to the Senior Director, Global Regulatory Affairs Labeling.

JOB FUNCTIONS/RESPONSIBILITIES

• Responsible for providing commercial regulatory leadership for assigned programs.

• Serve as a key Regulatory Advertising & Promotion subject-matter expert for advertising/promotional materials.

• Serve as regulatory liaison to the FDA/CDER/Office of Prescription Drug Promotion (OPDP) and other health agencies, as appropriate.

• Oversee or author commercial regulatory submissions and work closely with the Publishing vendor to ensure the timely submission of promotional materials to the Office of Prescription Drug Promotion (OPDP).

• Represent Commercial Regulatory Advertising and Promotion at labeling meetings and provide strategic regulatory guidance, as appropriate.

• Provide regulatory guidance on new concepts and new campaigns.

• Maintain current knowledge of applicable of FDA regulations, guidance documents, enforcement actions, and relevant regulatory precedents, and translate that knowledge into practical recommendations for the organization.

• Recognized as an expert resource for regulatory advice across departments.

• May contribute to process improvements relevant to commercial regulatory activities, including the MLR Committee.

• Responsible for the development and implementation of regulatory advertising and promotional processes, as necessary.

• Establish and maintain an effective tracking and planning system, including materials under review, upcoming deliverables, regulatory submissions, key milestones, deadlines, dependencies, and outstanding actions, to support visibility, prioritization, and timely execution.

• 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