Program Manager

About the RoleRole 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.ResponsibilitiesProgram Governance & Execution: Lead integrated program planning across CMC, device management, clinical, regulatory, supply chain. Drive governance forums and executive reportingBudget & Financial Management: Own program budget, forecasting, cost optimization and deliver variance analysis and financial insightsRegulatory Strategy Alignment: Align with FDA, EMA, and global Generics (Drug substance and Drug product) guidelines and support filing strategy and lifecycle managementR&D and Clinical Oversight: Coordinate development, strategy discussions, clinical studies execution and manage CRO and CMO engagements and timelines, as may be necessary.Stakeholder Management: Lead cross-functional alignment across internal/external partners and manage CMOs/CROs and contractual deliverablesRisk & Decision Management: Identify risks and implement mitigation strategies. Enable data-driven decision makingQualificationsMaster’s / PhD in Life Sciences in / Biotechnology / PharmacyPMP preferred8–15+ years in biopharmaceutical industryDemonstrated experience in Generics (Drug substance and Drug product) development programsRequired SkillsAdvanced program and financial management skillsStrong understanding of Generics (Drug substance and Drug product) regulatory pathways (US/EU)Cross-functional leadership and stakeholder managementExcellent communication and influencing skillsStrategic thinking and problem solvingKPIsOn-time milestone deliveryBudget adherence (% variance)Regulatory submission successRisk mitigation effectivenessStakeholder satisfactionLeadership Behaviour'sOwnership and accountabilityCollaboration and stakeholder alignmentAgility and adaptabilityContinuous improvement mindset