Mohit Doshi

Experience

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  SUN PHARMA

  Jul 2020 - Jan 2021

  Industrial Project Training

  Regulatory Activities related to DMF and Dossier Filling for Emerging markets- CHINA.

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  Torrent Pharmaceuticals Ltd

  Jun 2021 - Mar 2023

  Regulatory Affairs Executive

  • Preparation of e-CTD Dossier.• Timely submission of Query-Response of Agencies.• Preparation of Module 1/Administrative Documents.• Preparation & reviewing of CMC Dossier Sections • Handled Dossier Audit for Potential Customers.• Publishing of Dossier using ECTD software- “Pharma-Ready”.• Responsible for evaluating the Change Control for the Drug product and Impact evaluation.• Reviewing of Finished Product Specifications and Shelf-Life Specifications.• Evaluation of Trade Dress and Formula Clearance for New Products.• Validation of Dossier using “Lorenz E-validator” software.• Troubleshooting technical errors related to dossier compilation.• Preparation for Technical Information Transfer Documents (TITD) for commercial activity.• Various other miscellaneous regulatory activities such as baseline sequencing for European markets. Show less

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  ProductLife Group

  Mar 2023 - now

  Senior Regulatory Affairs Associate

  • Provide regulatory support to clients and associate companies. • Handling of Pre-Licensing ,New Registration Submission (RA Strategy) and post licensing submission activities via Veeva Vault.• Provide support and review for Linguistic review (LR) process on PI information for CP and MRP procedures.• Coordinate with GRA Lead for submission requirements and timely submission via Veeva Vault.• Handling M1 related documentation for DCP/MRP/NP Submission Management.• Managing client administrative documents and reports.• Compilation of regulatory dossiers in accordance with national requirements.• Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling based on QRD.• Document and track regulatory submissions and regulatory authority approval.• Search, extract, evaluate, compare data according to needs.• Proper e-Archival all of the file to respective folder.• Review of Mock ups as per EU requirements during the submission of dossiers• Provide on-going regulatory support to the Regulatory Affairs Specialist and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.• Contribute to data entry in PLG tools enabling measurements of KPI and metrics for regulatory services supplied by the platform/hub Show less