21 Aug
|
Sanofi
|
Hyderabad
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 current 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 negotiati
📌 GRA Labelling Group Lead (Hyderabad)
🏢 Sanofi
📍 Hyderabad