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 Accountabilities1.

Program

Governance &
Execution- Lead integrated program planning across CMC, device management, clinical, regulatory, and supply chain.
Drive governance forums and executive reporting2. Budget &
Financial Management- Own program budget, forecasting, and cost optimization- Deliver variance analysis and financial insights3.

Regulatory Strategy

Alignment- Align with FDA, EMA, and global Generics (Drug substance and Drug product) guidelines- Support filing strategy and lifecycle management4. 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 deliverables6. Risk &




Decision Management- Identify risks and implement mitigation strategies- Enable data-driven decision making Education &
Experience- Master’s / Ph D 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
🏢 Biocon
📍 Bengaluru