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
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 Generics (Drug substance and Drug product) 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 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