Job DescriptionRole Purpose The Manager – Program Management is responsible for end-to-end coordination, tracking, and enablement of global regulatory filings and approvals across biosimilars and generic product portfolios. The role works in close partnership with Regulatory Affairs and cross-functional teams to ensure predictable execution of submissions, approvals, and lifecycle activities. In addition, the role provides technical program support to technology transfer (Tech Transfer) activities on a case-by-case basis, coordinating inputs across functions to enable smooth execution. Key Responsibilities 1. Regulatory Filing & Approval Management - Own global tracking of regulatory filings, approvals, commitments, and health authority queries across molecules and markets. - Maintain molecule-wise and market-wise dashboards covering planned vs actual submissions and approvals. - Ensure accuracy, clarity, and timely updates of regulatory status to stakeholders. 2. Cross-Functional Team (CFT) Orchestration - Act as the primary coordination point between Regulatory Affairs, CMC,



Clinical, Quality, Supply Chain, and Commercial teams. - Identify critical path activities and interdependencies impacting submission and approval timelines. - Drive action closure across teams and escalate risks with data-backed mitigation options. 3. Filing Readiness & Execution Governance - Lead filing readiness checkpoints and support pre-submission planning activities. - Coordinate internal reviews for submissions, responses to health authority questions, and lifecycle changes. - Support execution discipline across submissions, variations, renewals, and post-approval commitments. 4. Technical Support for Tech Transfer Activities - Provide program-level technical coordination support for technology transfer activities on a case-to-case basis. - Coordinate inputs between CMC, MSAT, Manufacturing, Quality, Regulatory, and external partners during tech transfer phases. - Track tech transfer m

📌 Program Management (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru