01Overview
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 - Masters / PhD in Life Sciences in / Biotechnology / Pharmacy - PMP preferred - 815+ years in biopharmaceutical industry - Demonstrated experience in Generics (Drug substance and Drug product) development programs Competencies - Advanced program and financial management skills - Strong 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 .
