Advancing science and helping patients - these dual passions are ingrained in our culture. They drive our work, our values, and everything we do at Amgen. For staff around the world, our mission to serve patients and our commitment to science makes Amgen a place where we can make a positive difference in people's lives while pursuing a challenging and fulfilling career. To foster a setting in which all staff may excel, we support a variety of growth opportunities-from training and education to expanding current job responsibilities. Amgen is searching for a Latin America (LATAM) Regional Labeling Lead (RLL). This role will report to the Regional Labeling Senior Manager and will be based out of our main corporate campus in Thousand Oaks, CA. The Latin America (LATAM) Regional Labeling Lead (RLL), under the supervision of the Regional Labeling Senior Manager, manages and facilitates the development of comprehensive regional drug product labeling that are consistent with corporate strategy, and competitive with other agents in the class. The RLL is responsible for overseeing the development, review, approval and maintenance of Regional labeling documents for assigned products derived from core or reference product labeling. This will include: - Management of Regional labeling development and maintenance activities in partnership with the Regional Regulatory Leads (RRLs), Local Regulatory Representatives (LRRs) and Global Labeling Leads (GLLs) for assigned products. - Ensuring that Regional prescribing information (RPI), patient information leaflet (PIL), instructions for use (IFU), and package component labeling (PCL) is accurate, current, and consistent with core or reference product labeling, reviewed with Regional Review Teams, and that any deviations are justified/documented to the Global teams as appropriate. - Providing tactical guidance to RRLs and LRRS regarding Regional label content, development, and maintenance. - Independently making decisions regarding routine operations, process or business practices. Primary responsibilities of the role include: - Supporting RRLs and LRRs, in the creation, development, regional review, tracking and maintenance of Regional labeling documents (i.e., prescribing information, patient information, instructions for use and package component labeling). - Participating in regional and corporate reviews as necessary and ensuring that any deviations are justified to the appropriate governance body and documented appropriately. - Ensuring quality of Regional labeling deliverables, i.e., alignment of labeling text with data and regional regulatory requirements, consistency between a product's labeling documents. - Providing tactical guidance to regional product labeling review teams regarding Regional label development and maintenance. Analyzing various regulatory and labeling alternatives for drug product labeling and recommendsing alternatives to facilitate best possible patient and company outcomes. - Working with relevant internal and external partners to ensure execution of team deliverables, projects and initiatives. Training and mentoring team members. Contributing to the continuous improvement of the end-to-end labeling process. - Supporting corporate audits and regulatory inspections of Regional labeling processes. Maintaining awareness of regulatory legislation pertaining to labeling. - Independently creating and maintaining competitive labeling comparisons, proprietary regional labeling comparisons and precedent searches. Actively assessing impact of proposed labeling changes in relation to competitors. - Upon assignment / discretion of the Corporate Global Labeling Head or Regional Labeling Manager, participates in internal and external (cross-functional) special projects. - Executes goals aligned with corporate and department strategies and plans. Works with relevant internal and external partners to ensure execution of team deliverables, special