Job Description
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 ...
- 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 ...
Apply for This Position
Ready to take the next step? Click the button below to submit your application.
Submit Application