Lead end-to-end Injectable (Drug- Device Combination) development programs across R&D;, Clinical, Regulatory, and Manufacturing. Ensure delivery aligned to cost, timelines, and global regulatory expectations for advanced markets.
Key Accountabilities
Program Governance & Execution
Lead integrated program planning across CMC, device management, clinical, regulatory, and supply chain.
Drive governance forums and executive reporting
Budget & Financial Management
Own program budget, forecasting, and cost optimization
Deliver variance analysis and financial insights
Regulatory Strategy Alignment
Align with FDA, EMA, and global Injectable (Drug- Device Combination) guidelines
Support filing strategy and lifecycle management
R&D; and Clinical Oversight
Coordinate development, strategy discussions, clinical studies execution etc.
Manage CRO and CMO engagements and timelines, as may be necessary.
Stakeholder Management
Lead cross-functional alignment across internal and external partners
Manage CMOs/CROs and contractual deliverables
Risk & Decision Management
Identify risks and implement mitigation strategies
Enable data-driven decision making
Education & Experience
Master’s / PhD in Life Sciences in / Biotechnology / Pharmacy
PMP preferred
8–15+ years in biopharmaceutical industry
Demonstrated experience in Injectable (Drug- Device Combination) development programs
Competencies
Advanced program and financial management skills
Solid understanding of Injectable (Drug- Device Combination) regulatory pathways (US/EU)
Cross-functional leadership and stakeholder management
Excellent communication and influencing skills
Strategic thinking and problem solving
📌 Program Manager – Injectable Drug Device Combination Development Bengaluru
🏢 BIOCON BIOLOGICS
📍 Bengaluru
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