Global Labelling Lead
Core
Strategic and operational leadership for product labeling ensuring scientific integrity and regulatory compliance across global markets for Sobi pharmaceutical products.
Role type
Senior Regulatory Affairs Lead (Labeling Strategy)
Builds
Product labeling content (Core Data Sheets, US/EU Prescribing Information) and labeling governance processes
Domain
Pharmaceutical industry / Global Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy, cross-functional team leadership, global compliance management, project coordination, regulatory information systems proficiency, scientific discipline background
Preferred skills
Knowledge of non-US/EU labeling requirements, Instructions for Use (IFU) management experience
Technologies
Regulatory Information Management systems, MS-Office
Responsibilities
Lead content development and approval of Core Data Sheets and Product Information; Manage review and approval of country labeling for international filings; Ensure compliance with Health Authority regulations; Guide Labeling Working Groups in discussions with Health Authorities; Present new labeling content to Executive Labeling Committee; Maintain oversight of labeling compliance and safety variations; Support inspections and audits related to labeling activities
Seniority
Senior, hands-on IC with strategic oversight
