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

- Coordinate development, strategy discussi...