• Reporting to the Director of Global Labeling, the Manager, Global Labeling is responsible for supporting Global Labeling Leads in daily operational labeling activities (US and global) • Managing and maintaining US SPL, drug listings, and establishment registrations • Triaging, reviewing, and tracking Country Product Information (CPI) • Performing operational activities that support Global Labeling deliverables and responsibilities • Collaborate with key stakeholders to facilitate and lead cross-functional teams in the development, review, approval, and maintenance of the establishment registration and drug listing (bulk and finished) in the US • Perform bi-annual review and submission of FDA-required drug listings and establishment registrations • Act as a Subject Matter Expert (SME) on US Structured Product Labeling (SPL): Provide guidance and support for the U.S. drug listings and Structured Product Labeling (SPL), partner with an external service provider to deliver on SPL commitments • Collaborate with global stakeholders and stay abreast of structured product labeling developments, requirements, and formats in rest of world • Be familiar with National Drug Code (NDC), Dun and Bradstreet Number (DUNS), FDA Establishment Identification (FEI), and Global Trade Identification Number (GTIN) requirements • Review and track requests for updates to Country Product Information (CPI) and CPI components • Attend necessary labeling team meetings to discuss decisions regarding any label and CPI updates, discuss any findings of meaningful differences among Source Reference Labels (SRLs) and CPIs • Represent the Global Regulatory Services and Operations (GRSO), Global Labeling Group on project teams. • Support the use and development of current and new tools, technologies, and processes to support global label development, submission, approval, and dispatch of Source Reference Labels in and to respective countries in addition to global label support • Track periodic CCDS reviews to ensure compliance with internal procedures and timelines • Maintain labeling history documents and assist in responding to labeling-related queries from various functional areas • Ensure all actions taken within role follow applicable SOPs and associated documents so that high quality delivery of outputs and compliance is maintained • Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems • Participate in and contribute to the continuous improvement efforts related to business practices and tools utilized within role • Contribute and support the development and maintenance of job aids and guidance documents • Support compliance activities including audits, inspections, and labeling-related escalations and non-conformances.