About the Role

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.

Responsibilities

- Program Governance & Execution: Lead integrated program planning across CMC, device management, clinical, regulatory, supply chain. Drive governance forums and executive reporting
- Budget & Financial Management: Own program budget, forecasting, cost optimization and deliver variance analysis and financial insights
- Regulatory Strategy Alignment: Align with FDA, EMA, and global Generics (Drug substance and Drug product) guidelines and support filing strategy and lifecycle management
- R&D; and Clinical Oversight: Coordinate development, strategy discussions, clinical studies execution and manage CRO and CMO engagements and timelines, as may be necessary.
- Stakeholder Management: Lead cross-functional alignment across internal/external partners and manage CMOs/CROs and contractual deliverables
- Risk & Decision Management:



Identify risks and implement mitigation strategies. Enable data-driven decision making

Qualifications

- 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

Required Skills

- Advanced program and financial management skills
- Robust 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 Behaviour's

- Ownership and accountability
- Collaboration and stakeholder alignment
- Agility and adaptability
- Continuous improvement mindset

📌 Program Manager (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru