Job DescriptionRole Purpose NLead end-to-end biosimilar 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, 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 biosimilar 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 / Biotechnology / Pharmacy N- PMP preferredn-13+ years in biopharmaceutical industry N- Demonstrated experiencein biosimilar development programs NCompetenciesn- Advanced program and financial management skills N- Solid understanding ofbiosimilar regulatory pathways (US/EU) N- Cross-functional leadership and stakeholder management N- Excellent communicationand influencing skills N- Strategic thinking and problem solving

📌 Program Manager - Biosimilar Development (Karnataka)
🏢 BIOCON BIOLOGICS
📍 Karnataka