Asmita Tripathi
Officer- Global Regulatory Affairs (CMC) | M. Pharmacy | Registered Pharmacist | LL.B (Pursuing)
- Role
- Officer - Global Regulatory Affairs-chemistry Manufacturing & Control at Glenmark Pharmaceuticals
- Location
- Mumbai, IN
- LinkedIn followers
- 500 followers
About Asmita Tripathi
Regulatory Affairs professional leveraging a strong legal background to support…
Experience
Officer - Global Regulatory Affairs-chemistry Manufacturing & Control
Nov 2024 — Present · Mumbai, IN
Compilation of Dossiers as per the respective country regulations for various types of applications, for submission to Regulatory Authority in India. To achieve organizations business targets by timely submission of applications to DCGI as per applicable checklist and ensure quality for faster Product approval IND/NDA/MAA/SNDA/Import & Registration.• Ensure quick turnaround time to reply deficiencies, with technically sound responses to avoid repeated queries and ensure faster approvals.• Gap analysis of filling dossiers, and closing identified gaps satisfactorily. • Updating the project database & maintaining the product lifecycle to ensure all licenses are renewed prior to expiry. Tracking the submissions and approval status of applications • Support assigned Due Diligence activities for branded/generic developments and prepare the RA report identifying gaps in the development / dossier and providing an opinion on the suitability of the dossier.• Review and approval of change controls / specifications/ and artworks.• Review of clinical documentation of PI/Medical Rational/ Investigators Brochure/Protocols/ and other documentation to support dossier submission to DCGI/CDSCO.• Regulatory support for the Pharmacovigilance & safety reporting activity.
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