Mayur Katkade
|US Regulatory| |CMC Regulated Market| |Complex Formulation| |IND| |ANDA (Inhalations, Nasal, Injectable, Ophthalmic, Oral Solution, OSD & Ointment)| |Life Cycle Management| |Query Response|
- Role
- Regulatory Generics Lifecycle and International Submissions (Rgli) - Coe Us Team at Sandoz
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Mayur Katkade
NDAs, ANDAs, Biosimilar-351(k), INDs, Life Cycle Management and Query response: Complex…
Experience
Regulatory Generics Lifecycle and International Submissions (Rgli) - Coe Us Team
Oct 2023 — Present · Maharashtra, IN
US Scope -RGLI (Regulatory Generics Lifecycle and International Submissions:• Post approval submissions (PAS, CBE-30, CBE-0, Annual Reports).• Site Transfer Supplements.Query Responses (IR, DRL & CRL).• Working cross-functionally and collaborating with stakeholders/customers/CMO sites.• Change Controls evaluation and categorizations.
Skills
- Regulatory Affairs
- Actd Guidelines
- Ctd
- Dossier Preparation
- Row
- Dossier Compilation
- Drug Regulatory Affairs
- Regulatory Submissions
- Regulatory Documentation
- Regulatory Guidelines
- Regulatory Filings
- Usfda
- New Drug Application (Nda)
- Abbreviated New Drug Application (Anda)
- Anda
- Prefiling Anda
- Post Approval Fillings
- Prior Approval Supplement
- Cbe 30, Cbe 0 & Annual Reports
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