Job Description Role Purpose
n Lead 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.
n Key Accountabilities
n 1. Program Governance & Execution
n - Lead integrated program planning across CMC, device management, clinical, regulatory, and supply chain.
n - Drive governance forums and executive reporting
n 2. Budget & Financial Management
n - Own program budget, forecasting, and cost optimization
n - Deliver variance analysis and financial insights
n 3. Regulatory Strategy Alignment
n - Align with FDA, EMA, and global Generics (Drug substance and Drug product) guidelines
n - Support filing strategy and lifecycle management
n 4. 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.
n 5. Stakeholder Management




n - Lead cross-functional alignment across internal and external partners
n - Manage CMOs/CROs and contractual deliverables
n 6. Risk & Decision Management
n - Identify risks and implement mitigation strategies
n - Enable data-driven decision making
n Education & 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
n Competencies
n - Advanced program and financial management skills
n - Solid 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

📌 Program Manager - Generics (Drug substance and Drug product) (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru