Program Management Specialist

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 e...