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
- 5-8 years in biopharmaceutical industry
- Demonstrated experience in Generics (Drug substance and Drug product) development programs

Competency

- 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 Behaviours

- Ownership and accountability

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

📌 Program Management - Generics Consultant (Bengaluru)
🏢 Biocon
📍 Bengaluru