Executive- API RA
MaharashtraFull-time4–7 yrsPosted yesterday
Mid-level legal role at USV in Maharashtra. Needs 4+ years and an M.Sc.
About the role
This role focuses on strategic filing (DMF/CEP), maintaining the complete lifecycle of submissions through quality documentation, timely approvals and business continuity.
What you'll do
- Pre-approval - Prefilling Support and New DMF / CEP Fillings: Review of the various Pre-filling documents [TTD / Process / Specifications / Validations / Stability ext.]…
- Meeting submission timelines of assigned projects for identified markets
- Pre-approval - Deficiency Responses: Review comments of the various response documents with agreed timelines with stakeholders. Meeting submission timelines of assigned…
- Change control, Vendor Notifications and Deviations: Review of change controls, deviations, vendor notifications and their impact assessment on the submissions
- Post Approval - DMF / CEP Amendments [Post approval changes / variations]
What you need
- Regulatory affairs
- Negotiation
- GMP
- Chemistry
- Documentation