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 su...