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Program Management Specialist

Company

Biocon

Location

Bengaluru, Karnataka

Posted

June 04, 2026

Position Overview

Key Responsibilities1. 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 dis...

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