Team Lead GRA Labelling Strategist

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About the role

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, new 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 maintenance and compliance of existing Marketing Authorizations  • Anticipates any hurdles in implementation and acts to minimize them, informing management as needed • Coordinate, create and clearly present labeling proposals to Senior Executive Management via Labeling Review Committee • Assess relevant study reports, pharmacovigilance data (post-marketing) and any other scientific reports required for support labeling proposals. • Perform labeling competitive/comparator analysis to provide expert- level insights • Meet established submission timelines and quality standard for labeling deliverables. • Provide training/mentoring to team on CCDS, EU, & US guidance and regulations and strategy to implement into labeling text • Lead and support transversal or process improvement workstreams/projects • Execute training plans, assessing competency of team members, and closing individual training gaps through targeted development. • Conduct performance management—goal setting, feedback, and coaching—for a team. • Assign and balance product responsibility across a team based on capacity and skill level. • Manage resource planning and coverage across vacations, turnover, sick leave, and peak workloads without disrupting deliverables. • Ensures coverage for products/projects within the group, identifying possible gaps, resource constraints, and implement solutions to present to management • Forecast capacity against portfolio demand and reallocate work when gaps emerge. About you • Experience : Knowledge of regulatory and labeling requirements in major markets pertaining to marketing authorization filings for new products or updates to existing marketed products. Knowledge of the dynamics of Labeling Team purpose and objectives. • Strong knowledge

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