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

1. Budget & Financial Management

- Own program budget, forecasting, and cost optimization
- Deliver variance analysis and financial insights

1. Regulatory Strategy Alignment

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

1. R&D; and Clinical Oversight

- Coordinate development, strategy discussions, clinical studies execution etc.
- Manage CRO and CMO engagements and timelines, as may be necessary.

1. Stakeholder Management





- Lead cross-functional alignment across internal and external partners
- Manage CMOs/CROs and contractual deliverables

1. 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

📌 Generics Development Program Lead (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru