Associate Director, Regulatory Affairs Advertising and Promotion (Foster City)

Foster City

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to advancing scientific discoveries into medicines for rare disease patients. We are passionate about transforming research into important treatments, and we seek individuals who embody our values: care, be real, get it done, and have fun, seriously.

The Associate Director, Regulatory Affairs Advertising and Promotion provides regulatory guidance on commercial regulatory activities to enable the business to meet its commercial needs in a compliant manner. This role is part of the Medical, Legal and Regulatory (MLR) team and reports to the Director, Global Regulatory Affairs Advertising and Promotion.

• Provide commercial regulatory oversight for assigned programs.
• Manage and author commercial regulatory submissions, working closely with the publishing vendor to ensure timely publishing and submission of promotional materials to the Office of Prescription Drug Promotion (OPDP).
• Provide regulatory guidance on new concepts and new campaigns.
• Maintain awareness of FDA regulations, guidance documents, and enforcement actions regarding advertising and promotion of pharmaceutical products.
• Serve as a resource for commercial regulatory advice across departments.
• Contribute to process improvements relevant to commercial regulatory activities, including the MLR Committee.
• Aid in the development and implementation of regulatory advertising and promotional processes as necessary.

• Bachelor’s or advanced degree in a scientific discipline, with minimum 8 years in Regulatory Affairs, at least 6 years reviewing advertising and promotional materials for prescription drugs or biologics.
• Desirable: Experience representing Commercial Regulatory Affairs on cross‑functional teams.
• Excellent planning, organizational, and multi‑project management skills with tight timelines.
• Excellent written and verbal communication skills.

• Experience with the Office of Prescription Drug Promotion (OPDP) submissions and strategies.
• In‑depth knowledge of regulatory requirements for advertising and promotion of prescription drugs.
• Knowledge of laws and regulations for global pharmaceutical marketing (ROW) is highly desired.
• Strong verbal, written, negotiation, influence, and interpersonal communication skills.
• Ability to critically review complex technical and scientific documents and influence colleagues across functions.
• Independent and team orientation, ability to set priorities and meet timelines, and influence stakeholders.
• Organized, systematic approach to prioritization.
• Process oriented to achieve business objectives; able to thrive in a high‑growth, fast‑paced organization.
• Some travel required. May need to work outside normal hours to meet global demands.

Salary range: $205,000 – $225,000 USD. Compensation will be determined based on skill set, experience, and geographic location.

Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and complies with all federal, state, and local laws prohibiting employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition, disability, veteran status, or any other protected classification.

Mirum provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.