Role PurposeLead 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.Key Accountabilities1 . Program Governance & Execution- Lead integrated program planning across CMC, clinical, regulatory, and supply chain- Drive governance forums and executive reporting2. Budget & Financial Management- Own program budget, forecasting, and cost optimization- Deliver variance analysis and financial insights3. Regulatory Strategy Alignment- Align with FDA, EMA, and global biosimilar guidelines- Support filing strategy and lifecycle management4. 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 deliverables6. Risk & Decision Management- Identify risks and implement mitigation strategies- Enable data-driven decision makingEducation & Experience- Master’s / PhD in Life Sciences / Biotechnology / Pharmacy- PMP preferred- 13+ years in biopharmaceutical industry- Demonstrated experience in biosimilar development programsCompetencies- Advanced program and financial management skills- Solid understanding of biosimilar regulatory pathways (US/EU)- Cross-functional leadership and stakeholder management- Excellent communication and influencing skills- Strategic thinking and problem solving

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