Program Management – 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 discussions, clinical studies execution etc. - Manage CRO and CMO engagements and timelines, as may be necessary. 5. Stakeholder Management - Lead cross-functional alignment across internal and external partners - Manage CMOs/CROs and contractual deliverables 6. Risk & Decision Management - Identify risks and implement mitigation strategies - Enable data-driven decision making Education & Experience - Master’s / PhD in Life Sciences in / Biotechnology / Pharmacy - PMP preferred - 8–15 years in biopharmaceutical industry - Demonstrated experience in Generics (Drug substance and Drug product) development programs Competencies - Advanced program and financial management skills - Strong understanding of Generics (Drug substance and Drug product) regulatory pathways (US/EU) - Cross-functional leadership and stakeholder management - Excellent communication and influencing skills - Strategic thinking and problem solving KPIs - On-time milestone delivery - Budget adherence (% variance) - Regulatory submission success - Risk mitigation effectiveness - Stakeholder satisfaction Leadership behaviors - Ownership and accountability - Collaboration and stakeholder alignment - Agility and adaptability - Continuous improvement mindset