Job DescriptionRole Purpose NLead 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. NKey Accountabilitiesn1. Program Governance & Execution N- Lead integrated programplanning across CMC, device management, clinical, regulatory, and supply chain. N- Drive governance forumsand executive reporting N2. Budget & Financial Management N- Own program budget, forecasting, and cost optimization N- Deliver variance analysis and financial insights N3. Regulatory Strategy Alignment N- Align with FDA, EMA, and global Generics (Drug substance and Drug product) guidelines N- Support filing strategyand lifecycle management N4. R&D; and Clinical Oversight N- Coordinate development,strategy discussions, clinical studies execution etc. N- Manage CRO and CMO engagements and timelines, as may be necessary. N5. Stakeholder Management N- Lead cross-functional alignment across internal and external partners N- Manage CMOs/CROs and contractual deliverables N6.



Risk & Decision Management N- Identify risks and implement mitigation strategies N- Enable data-driven decision making NEducation & Experience N- Master's / PhD in Life Sciences in / Biotechnology / Pharmacy N- PMP preferredn-8–15+ years in biopharmaceutical industry N- Demonstrated experiencein Generics (Drug substance and Drug product) development programs NCompetenciesn- Advanced program and financial management skills N- Robust understanding ofGenerics (Drug substance and Drug product) regulatory pathways (US/EU) N- Cross-functional leadership and stakeholder management N- Excellent communicationand influencing skills N- Strategic thinking and problem solving NKPIsn- On-time milestone delivery N- Budget adherence (% variance) N- Regulatory submission success N- Risk mitigation effectiveness N- Stakeholder satisfaction NLeadership behaviorsn- Ownership and accountability N- Collaboration and stakeholder alignment N- Agility and adaptability N- Continuous improvement mindset

📌 Program Management - Generics (Drug Substance And Drug Product) (Vasanthanagar)
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📍 Vasanthanagar