Role Purpose Lead 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 making Education &
- Experience- Master’s / Ph D in Life Sciences / Biotechnology / Pharmacy- PMP preferred- 13+ years in biopharmaceutical industry- Demonstrated experience in biosimilar development programs Competencies- 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 (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru