Program Manager

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
• 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 Behaviour's

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