Program Manager

Biocon Biologics Limited; Bengaluru; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Biocon Biologics Limited is seeking an senior program leader to drive end-to-end Generics development programs (drug substance and drug product) across R&D, clinical, regulatory, and manufacturing. You will ensure delivery aligns with cost, timelines, and global regulatory expectations for advanced markets.

The role entails coordinating governance, budgeting, regulatory strategies, CRO/CMO management, and stakeholder alignment to deliver robust programs in a fast-paced biopharma environment.

Qualifications

• 8–15+ years in biopharmaceutical industry.
• Experience in Generics (Drug substance and Drug product) development.
• Master’s/PhD in Life Sciences or related field.

Responsibilities

• Lead integrated program planning across CMC, device management, clinical, regulatory, supply chain.
• Drive governance forums and executive reporting.
• Own program budget, forecasting, cost optimization and deliver variance analysis and financial insights.
• Align with FDA, EMA, and global Generics guidelines and support filing strategy and lifecycle management.
• Coordinate development, strategy discussions, clinical studies execution and manage CRO and CMO engagements and timelines.
• Lead cross-functional alignment across internal/external partners and manage CMOs/CROs and contractual deliverables.
• Identify risks and implement mitigation strategies. Enable data-driven decision making.

Skills

Program management

Financial management

Regulatory knowledge

Cross-functional leadership

Communication skills

Education

Master’s/PhD in Life Sciences

PMP

Job description

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