Program Manager - Generics (Drug substance and Drug product)

Role Purpose Lead end-to-end Generics (Drug substance and Drug product) development programs across R&D, Clinical, Regulatory, and Manufacturing. Ensure delivery aligned to cost, timelines, and global regulatory expectations for advanced markets. Key Accountabilities 1. Program Governance & Execution - Lead integrated program planning across CMC, device management, clinical, regulatory, and supply chain. - Drive governance forums and executive reporting 2. Budget & Financial Management - Own program budget, forecasting, and cost optimization - Deliver variance analysis and financial insights 3. Regulatory Strategy Alignment - Align with FDA, EMA, and global Generics (Drug substance and Drug product) guidelines - Support filing strategy and lifecycle management 4. R&D and Clinical Oversight