Program Management - Generics Consultant

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
- Strong 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