Program Management - Biosimilar

Biocon Biologics Limited; Bengaluru; On-site; INR 3,500,000 - 5,200,000; Full time

Job summary

Biocon Biologics Limited in Bengaluru seeks a senior program leader to drive end-to-end biosimilar development across R&D, clinical, regulatory and manufacturing.

You will own governance, budget, and regulatory strategy, oversee CROs/CMOs, and align cross-functional teams to deliver on time within global guidelines. This role demands strategic thinking, strong communication, and deep biosimilar experience.

Qualifications

• 12+ years in biopharmaceutical industry
• Demonstrated experience in biosimilar development programs
• Advanced program and financial management skills
• Strong understanding of biosimilar regulatory pathways (US/EU)
• Cross-functional leadership and stakeholder management
• Excellent communication and influencing skills
• Strategic thinking and problem solving

Responsibilities

• Lead integrated program planning across CMC, clinical, regulatory, and supply chain
• Drive governance forums and executive reporting
• Own program budget, forecasting, and cost optimization
• Deliver variance analysis and financial insights
• Align with FDA, EMA, and global biosimilar guidelines
• Support filing strategy and lifecycle management
• Manage CRO and CMO engagements and timelines, as may be necessary
• Lead cross-functional alignment across internal and external partners
• Manage CMOs/CROs and contractual deliverables
• Identify risks and implement mitigation strategies

Skills

Leadership

Biosimilar development

Program management

Budgeting & forecasting

Regulatory pathways (US/EU)

Cross-functional collaboration

Education

Master’s / PhD in Life Sciences / Biotechnology / Pharmacy

PMP certification (preferred)

Job description

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe.

About the Role:

Lead end-to-end biosimilar 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, 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 biosimilar guidelines
• Support filing strategy and lifecycle management

4. R&D and Clinical Oversight

• 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
• Identify risks and implement mitigation strategies
• Master’s / PhD in Life Sciences / Biotechnology / Pharmacy
• PMP preferred

Experience Required:

• 12+ years in biopharmaceutical industry
• Demonstrated experience in biosimilar development programs
• Advanced program and financial management skills
• Strong understanding of biosimilar regulatory pathways (US/EU)
• Cross-functional leadership and stakeholder management
• Excellent communication and influencing skills
• Strategic thinking and problem solving