• Lead the Global Labeling function for Ultragenyx and serve as an internal expert on health agency regulations and guidelines. • Accountable for oversight of the labeling process at Ultragenyx for all programs in development through commercialization. • Provide strategic and operational leadership in accordance with business goals and objectives, regulations, and guidelines. • Guide, develop and author draft labeling text (e.g., USPI, PPI, MedGuide, EU SmPC, EU PIL) to support marketing applications and labeling updates of approved package inserts to support product lifecycle management. • Ensure labeling strategy is aligned with overall regulatory and program strategy by working closely with the regulatory head, strategy lead and development and project teams. • Confirm labeling is compliant with US and EU regulatory requirements. • Develop and maintain CCDS. • Provides strategic regulatory guidance and expert advice on current labeling requirements, templates, tools and Health Authority-issued guidance across the portfolios globally. • Chairs the process to obtain labeling approval by Senior Management providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels. • Ability to lead, manage, motivate, mentor and develop a diverse team of Global Labeling Strategy Leads accountable for developing and reviewing and finalizing labeling across all development programs through commercialization. • Ability to lead, manage, motivate and develop Global Labeling Operations Leads accountable for overseeing packaging and artwork strategies across all commercial product lifecycles.