Pavan Pardeshi

Experience

1. Regulatory Affairs Officer

   Lupin

   Jun 2023 — Present

   Responsible for compiling and reviewing regulatory submissions for new ANDAs, lifecycle management, and deficiency responses for Nasal and Inhalation drug products.*Review and submission of controlled correspondences, Pre-ANDA product development meeting request/meeting package, Post CRL Scientific meeting request/package and Type C meeting request/package to seek Agency’s concurrence for Development of Complex Generics/ to respond deficiencies.* Assessment, Evaluation and Compilation of high quality deficiency responses for deficiency received from Agency (i.e. IR, DRL, CRL etc.) during registration within stipulated timeframe.*Review and evaluation of change controls as per regulatory perspective.*Post approval submissions such as Annual Reports, CBE, CBE-30, and PAS for life cycle management of approved products.*Review of R&D (MFC, Stability Protocols, API & FP Specifications, IIG Clearance and PDR etc.) and CMC documents (BMRs, BPRs, Specifications, STPs, COAs, Validation protocols and Reports, Stability Protocols & Reports and Stability data etc.) from regulatory perspective and work with cross functional teams for tracking of submission documents.*Drafted and reviewed Modules 1, 2, and 3 of eCTD as per US FDA requirements.*Coordinated with R&D, QA, QC, and manufacturing teams to collect and verify technical data.*Responsible for Preparation and Review of Labelling Pieces for Original and other regulatory submissions (such as PIL, Medication Guide, Instruction for Use, SBS, draft label for Artwork development and SPL).*Processing of PDF files as per regulatory requirement and eCTD compilation, verification and publishing activity.*Managed correspondence with the USFDA and tracked status of regulatory submissions.*Participated in regulatory strategy meetings for new product filings and post-approval changes

Education

• Pune District Education Associations Seth Govind Raghunath Sable College of Pharmacy, Saswad

  B.pharm

  2017 — 2021