Wasim Hasan

Experience

• 

  Freyr Solutions

  Apr 2014 - Apr 2018

  Was engaged as a Submission Publisher for Alcon Research Ltd. (A Novartis Division)Contractually associated with Novartis as Global Submission Publisher and execute publishing of NeeS and eCTD submissions to US, EU, ROW and GCC regions as per the process accordingly. Furthermore, act upon following listed activitiesClient: Novartis Pharmaceuticals (On shore Publishing team)• Archiving of safety submissions.• Publishing eCTD Renewal Submissions for Oman MoH.• Execute assigned Swissmedic submission.• Execute publishing of following submissions for US Protocol amendment Information amendment General Correspondence Annual Reports and DSUR CMC Supplements Safety Submissions• Perform publishing of following submissions for EU CP Submissions Renewals Variation Type II, 1A and 1B (National, DCP & MRP) Answer to HA Questions (Responses to HA) CTA Originals, Amendments and AtoQ’s.Client: Alcon Research Ltd. (A Novartis Division)• Routine publishing of Maintenance NeeS and eCTD packages to EU, GCC, ROW and US.• Carry out publishing of following submissions Original IND Briefing Book (Along with Desk copies) Annual Reports. IND DSUR PADER & SUSAR PSUR T-DOC’s Clinical Publishing MA Transfers• Responsible for publishing of following Medical device packages CE Technical File 510k Application IDE Final Report Australian Addendum 30 Days Notice Show less - Execute Pre-Publishing activities like creating Bookmark, TOC's and Hyperlinks (Internal and External).- Post-Publishing activities involving QC and fixing validation errors in published output.- Finally performing quality assurance of published output for completeness and correctness in terms of document navigation and other technical aspects. Thereby ensuring that all the files in dossier are as per validation criteria.- Perform quality check of submission compiled and published by team members. Communicating and Updating of any project concerns/issues to Project Manager/Client. Show less

  • Senior Associate Regulatory Operations

    Apr 2017 - Apr 2018

  • Associate Regulatory Operations

    Apr 2015 - Mar 2017

  • Trainee Regulatory Operations

    Apr 2014 - Mar 2015
• 

  National Pharmaceutical Industries Co (SAOC) - Oman

  May 2018 - Jul 2021

  Global Scientific & Regulatory Affairs Officer

  • Preparing, Reviewing & Monitoring New submission dossier, annual reports, renewals, and variation for approved products.• Thoroughly review and check all technical data (e.g. Stability Summary Reports, Leaflets & Artworks, Specifications), Regional Certificate requirement, Samples and CMC documents for accuracy and correctness of data for compilation of the dossier.• Liaising with diverse departments namely QA, QC, R&D, ADL Supply chain and Marketing for the technical data.• Compilation of dossier using eCTD software and validating the same.• Submission of dossier as planned for different regions.• Preparation and submission of planned variation involving technical changes like change in specification / artwork / shelf life / storage conditions and liaise with cross functional departments for necessary documents.• To prepare, review and submit data pertaining to regulatory bodies observation/queries and respond within time-frame. Show less

• 

  Acino

  Aug 2021 - now

  1. Perform due diligence and advice business development on module 2-5, specifically on quality part for the dossier received from the technology transfer unit for local registration.2. Provide answers to the quality question in deficiency letters from health authorities received during any regulatory submissions.3. Write the Chemistry Manufacturing Control (CMC) part of Modules 2 and 3. Then compile, review, upload modules 2, 3, 4 and 5 of the local regulatory dossiers and publish in CTD/eCTD using Lorenz docuBridge.4. Create and maintain a full up-to-date database and archiving system for tracking the regulatory activities in the region on RIMS Lorenz drugTrack.5. Review change control and Coordinate Regulatory activity submission to authority.6. Support the preparation and translation. Subsequently, proofread printed artwork ensuringcompliance with the registered Product Information.7. Manage the corresponding business partners and monitor all regulatory activities performed by them.8. Work closely with commercial and supply chain to ensure the continuity of supply during the submission of changes and no business interruption of the registered products in the country. Show less

  • Assistant Manager - Regulatory Affairs

    Nov 2023 - now

  • Regulatory Affairs Specialist

    Aug 2021 - Jan 2024