Job DescriptionAt 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.
nAbout the Role:
nLead 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.
nKey Accountabilities
n1. Program Governance & Execution
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Lead integrated program planning across CMC, clinical, regulatory,



and supply chainn
Drive governance forums and executive reportingn

n2. Budget & Financial Management
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Own program budget, forecasting, and cost optimizationn
Deliver variance analysis and financial insightsn

n3. Regulatory Strategy Alignment
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Align with FDA, EMA, and global biosimilar guidelinesn
Support filing strategy and lifecycle managementn

n4. R&D; and Clinical Oversight
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Coordinate development, strategy discussions, clinical studies execution etc.n
Manage CRO and CMO engagements and timelines, as may be necessary.n

n5. Stakeholder Management
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Lead cross-functional alignment across internal and external partnersn
Manage CMOs/CROs and contractual deliverablesn

n6. Risk & Decision Management
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Identify risks and implement mitigation strategiesn
Enable data-driven decision makingn

nAcademics Background:
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Maste

📌 Program Management Karnataka
🏢 BIOCON BIOLOGICS
📍 Karnataka