GRA Labelling Group Lead

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About the role

Job title: GRA Labelling Group Lead Location : Hyderabad (Hybrid) About the job Our Team: Drive Labeling Value to maximize Sanofi´s competitive advantage Main responsibilities: • Recruit, hire, and onboard team members, including defining role competencies and evaluating candidates. • Build and executing 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. • Develop contingency/backup coverage models so no product goes unowned. • Track and report status across a large portfolio using dashboards, trackers, or portfolio management tools. • Establishing and monitoring KPIs/metrics for quality and timeliness (e.g., on-time submission rate, errors/deviation rate, cycle time). • Utilize project/portfolio management methods for competing deadlines across 250 products. • Define and Lead Labeling strategists to create or update corporate labeling documents (CCDS, US, EU, WHO) and corresponding patient leaflet for development projects (including TPL) and complex LCM/marketed products within the framework of regulatory submissions to obtain new Marketing Authorizations or to update existing Marketing Authorizations, obtain company and/or agency approval. • Coordination and accountability of the team through the 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 (including early development TPL creation), marketed and LCM products (including complex updates and line extensions) and due diligence opportunities. • Ensure team’s ability to support cross-functional teams as a labeling expert (within and outside 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 • Ensure team’s ability to chair 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 and guidance for team and assigned products and provide strategic guidance and training as needed for complex labeling projects (including review and validation of labelling proposals as needed), informing management as necessary. • Extended GRA Labelling Leadership team representative • Be a member of Response Teams within procedures for EU and US Procedures for highly 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 • Identifies risks and anticipates any hurdles in implementation for the product portfolio and acts to minimize them, informing management as needed. • Ensure coordination, creation and clear presentation of labeling proposals to Senior Executive Management via Labeling Review Commit

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