Location
Bengaluru
Job Type
Full-time
Posted
May 22, 2026
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, a...
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, a...