• The Global Labeling Lead (GLL) serves as a labeling strategy expert for Sobi products within Global Regulatory Affairs (GRA). • Provide both strategic and operational leadership for product labeling, working closely with Regulatory Strategy Leads and other cross-functional stakeholders. • Lead the content development, approval, and maintenance of the Company Core Data Sheet (CCDS) and US/EU Product Information (PI). • Manage the review and approval of country labeling for new filings in international markets. • Ensure compliance with relevant Health Authority (HA) regulations, internal procedures, and business objectives. • Support continuous improvement of labeling processes and systems. • Lead the development, implementation, and maintenance of the CCDS, USPI and EU PI for assigned Sobi products throughout the product lifecycle via cross-functional Labeling Working Groups (LWG). • Guide LWGs in labeling discussions with HAs, while ensuring management alignment and adherence to labeling governance. • Collaborate closely with internal stakeholders and partner companies, as applicable. • Document and archive LWG decisions and outcomes. • Present new labeling content and major updates to the Executive Labeling Committee for approval. • Partner with international Regulatory Affairs (RA) to guide the review and approval process of labels for submission outside of EU and US. • Maintain oversight of labeling compliance, including documentation of labeling content deviations and end-to-end tracking of safety variations. • Contribute to the development and improvement of labeling processes, including creation and review of process documents. • Support inspections and audits related to labeling activities. • Participate in cross-functional and cross-regional initiatives to strengthen collaboration and increase operational efficiencies.

• The Global Labeling Lead (GLL) serves as a labeling strategy expert for Sobi products within Global Regulatory Affairs (GRA). • The GLL provides both strategic and operational leadership for product labeling, working closely with Regulatory Strategy Leads and other cross-functional stakeholders. • Ensure compliance with relevant Health Authority (HA) regulations, internal procedures, and business objectives. • Support continuous improvement of labeling processes and systems. • Lead the development, implementation, and maintenance of the CCDS, USPI and EU PI for assigned Sobi products throughout the product lifecycle via cross-functional Labeling Working Groups (LWG). • Document and archive LWG decisions and outcomes. • Partner with international Regulatory Affairs (RA) to guide the review and approval process of labels for submission outside of EU and US. • Maintain oversight of labeling compliance, including documentation of labeling content deviations and end-to-end tracking of safety variations.

• Lead the content development, approval, and maintenance of the Company Core Data Sheet (CCDS) and US/EU Product Information (PI). • Manage the review and approval of country labeling for new filings in international markets. • Ensure compliance with relevant Health Authority (HA) regulations, internal procedures, and business objectives. • Support continuous improvement of labeling processes and systems. • Guide LWGs in labeling discussions with HAs, while ensuring management alignment and adherence to labeling governance. • Collaborate closely with internal stakeholders and partner companies, as applicable. • Document and archive LWG decisions and outcomes. • Present new labeling content and major updates to the Executive Labeling Committee for approval. • Partner with international Regulatory Affairs (RA) to guide the review and approval process of labels for submission outside of EU and US. • Maintain oversight of labeling compliance, including documentation of labeling content deviations and end-to-end tracking of safety variations. • Contribute to the development and improvement of labeling processes, including creation and review of process documents. • Support inspections and audits related to labeling activities. • Participate in cross-functional and cross-regional initiatives to strengthen collaboration and increase operational efficiencies.

• Label entities such as material identities, composition specifications, material states, and sources. • Record composition constituents, amounts, and units exactly as written. • Capture stated links such as material-to-composition, material-to-state, claim/example relationships, and coreference. • Preserve span IDs and verbatim text needed for later resolution. • Leave external classification, normalization, equivalence mapping, unit defaulting, and material-family decisions to a separate expert resolution process. • Nice to have/stretch: help develop or evaluate LLM-assisted annotation workflows that improve productivity while preserving human review quality.