Program Management - Generics Consultant

Job description

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 • Masters / PhD in Life Sciences in / Biotechnology / Pharmacy • PMP preferred • 5-8 years in biopharmaceutical industry • Demonstrated experience in Generics (Drug substance and Drug product) development programs Competency • 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 Behaviours • Ownership and accountability • Collaboration and stakeholder alignment • Agility and adaptability • Continuous improvement mindset