Role Purpose 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.

Key Accountabilities 1.

Program

Governance & Execution - Lead integrated program planning across CMC, device management, clinical, regulatory, and supply chain.
Drive governance forums and executive reporting 2. Budget & Financial Management - Own program budget, forecasting, and cost optimization - Deliver variance analysis and financial insights 3.

Regulatory Strategy

Alignment - Align with FDA, EMA, and global Generics (Drug substance and Drug product) guidelines - Support filing strategy and lifecycle management 4. 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 deliverables 6.



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 Generics (Drug substance and Drug product) development programs Competencies - Advanced program and financial management skills - Solid understanding of Generics (Drug substance and Drug product) regulatory pathways (US/EU) - Cross-functional leadership and stakeholder management - Excellent communication and influencing skills - Strategic thinking and problem solving KPIs - On-time milestone delivery - Budget adherence (% variance) - Regulatory submission success - Risk mitigation effectiveness - Stakeholder satisfaction Leadership behaviors - Ownership and accountability - Collaboration and stakeholder alignment - Agility and adaptability - Continuous improvement mindset

📌 Program Management – Generics Drug Substance And Drug Product Bengaluru (India)
🏢 Biocon
📍 India