Job title: Team Lead GRA Labeling Strategist
Location: Hyderabad, India (Hybrid model)
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 negotiations with agencies resulting in product approvals or labeling updates, and release of labeling for use throughout the company for development, marketed and LCM products (including complex updates, line extensions, recent indications).




Support cross-functional teams as a labeling expert (within GRAL, GRT and GRA) and contribute to the definition of global regulatory strategies and to the preparation of labeling components of submission dossiers or responses to Health Authorities
Chairs multi-disciplinary labeling working groups, presenting labeling proposals and developing/reaching consensus on proposals resulting in presentation of labeling proposals to the Labeling Governance Committee for internal approval of proposed labeling.
Provides oversight for team and assigned products, and provides strategic guidance and training on projects (including review and validation of Labeling proposals as needed), informing management as necessary
Be a member of Response Teams within procedures for EU and US Procedures including complex issues (e.g. European Arbitration/referrals, or work sharing, PRAC questions (signal detection, Labeling negotiations, Urgent Safety restrictions…) for the mainten

📌 Team Lead GRA Labelling Strategist (Hyderabad)
🏢 Sanofi
📍 Hyderabad