We are seeking an experienced Manager / Senior Manager Regulatory Affairs (API) to join our Regulatory Affairs team. The candidate will be responsible for API regulatory submissions, DMF/ASMF, dossier preparation, regulatory compliance, product registration and lifecycle management across domestic and international markets.
Key Responsibilities
- Manage API Regulatory Affairs activities.
- Prepare, review and submit DMF / ASMF / CTD dossiers.
- Handle regulatory submissions, amendments, variations and renewals.
- Prepare responses to regulatory queries and deficiencies.
- Manage post-approval changes and regulatory lifecycle activities.
- Coordinate with R&D;, QA, QC, Production and other cross-functional teams.
- Ensure compliance with USFDA, EU and applicable regulatory guidelines.
- Track regulatory submissions, approvals and commitments.
- Review regulatory documents and ensure timely submission.
- Support regulatory audits and inspections when required.
📌 Manager & Sr Manager Regulatory Affairs(RA) API (Vadodara)
🏢 Navlakha Management Services
📍 Vadodara
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