Sanket Pisal
Executive-Regulatory affairs .
- Role
- Executive - Regulatory Affairs at Intas Pharmaceuticals
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Sanket Pisal
Working for global regulatory operations-Experience in creation of various type of submissions and application like US,EU, UK, Corporate dispatch, site registration,ROW submission- great knowledge and experience for EU,UK and US markets-Upload Health authority correspondence- Update and upload FDA form in RSDM,356H,2252,1571,etc-Client handling-Audit experience -Correction request -Archival request -RADR,RSDM,BDLM access and issue request-Qc of submission and Correspondence-working with eCTD,non eCTD Migration only dossier type of submissions-Migration for various products- Issue resolution for various type of document like Quality, clinical, regulatory,etc. in Vault RIM-Tool handling like vault RIM,APPAIN,7Zip,abode AcrobatDC-Formatting assistance for the Literature documents-document ready for the submission activity-Reliant publishing-RIMS management system -Handling procadge application for information management- Mange variation information related to the type IAIN, type IB,IA,type II etc- life cycle management of uploaded products-update submission variation details for global regulatory-creation of binder in vault RIM -eCTD publishing -eDOK document formatting for submission-handling CESP,MHRA,EMA submission- promotional labelling activities (veeva vault promomat)
Experience
Executive - Regulatory Affairs
Aug 2024 — Present · Ahmedabad, IN
Management of global regulatory information for EU market.Manage and update the submission dossier information pre and post approval changes.Working on type IAIN,type II,Type IB etc type of submission information.Handling of mailbox and management activities. Life cycle maintenance update (renewal approval) of all uploaded procedures in RIMS application.Quality control checking of all data uploaded in RIMS database.ADHOC activities.Handling CESP,MHRA,EMA submissions.Great knowledge about module 1,2,3 and 5.
Education
Dr. Babasaheb Ambedkar Technological University
Bachelor of Pharmacy - BPharm
Dr D Y Patil Institute of Management Studies (DYPIMS)
Master of Business Administration - MBA
2022 — 2024
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