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 Accountabilities
n1. Program Governance & Execution
n- Lead integrated program planning across CMC, device management, clinical, regulatory, and supply chain.
n- Drive governance forums and 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 strategy and 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 preferred
n- 8–15+ years in biopharmaceutical industry
n- Demonstrated experience in Generics (Drug substance and Drug product) development programs
nCompetencies
n- Advanced program and financial management skills
n- Robust understanding of Generics (Drug substance and Drug product) regulatory pathways (US/EU)
n- Cross-functional leadership and stakeholder management
n- Excellent communication and influencing skills
n- Strategic thinking and problem solving
nKPIs
n- On-time milestone delivery
n- Budget adherence (% variance)
n- Regulatory submission success
n- Risk mitigation effectiveness
n- Stakeholder sat

📌 Program Management (Karnataka)
🏢 Biocon
📍 Karnataka