Senior Manager, Regulatory Affairs Labeling

Role: Senior Manager, Regulatory Affairs Labeling, providing regulatory expertise to develop and execute global labeling strategies for Mirum's marketed and development products. Responsibilities include creating and updating labeling content (CCDS, prescribing info, patient info), ensuring compliance with local regulations, managing labeling projects, representing Regulatory Affairs in labeling meetings, and liaising with external partners and international teams. The role also involves authoring regulatory submissions, maintaining labeling archives, and contributing to process improvements. Qualifications: Bachelor's or advanced degree in a scientific discipline with 3-6+ years of regulatory labeling experience in biopharma, with experience in US, EU, and global markets preferred. Skills include strong communication, negotiation, project management, and the ability to review complex scientific documents. High-value specifics: experience with pharmaceutical labeling regulations (FDA, EMA), global markets including LATAM, Middle East, Asia-Pacific, and familiarity with Veeva Vault RIM and QualityDocs. The position requires working in a fast-paced, high-growth environment, with some travel and flexibility in work hours. Reporting to the Senior Director, Global Commercial Regulatory Affairs & Labeling, the role involves cross-functional collaboration with Medical Affairs, Legal, Clinical Development, and Supply Chain teams.