Team Lead GRA Labeling Strategist Transversal

Job title : Team Lead GRA Labeling Strategist Location: Hyderabad, India ( Hybrid) About the job Our Team: Drive Labeling value to maximize Sanofi´s competitive advantage ​ ​ Main responsibilities: Define and Lead Labeling strategy to create or update corporate labeling documents (CCDS, US, EU, WHO) and corresponding patient leaflet for development projects and LCM/marketed products (including TPL for new indications) within the framework of regulatory submissions to obtain new Marketing Authorizations or to update existing Marketing Authorizations, obtain company and/or agency approval Coordination of labeling review and approval throughout the E2E labeling process, which includes preparation of labeling components for submission to regulatory agencies, participation in labeling negotiati…