Hemangi Kasla

Experience

• 

  Auxano Technologies Ltd

  Jun 2011 - Jan 2012

  Data Analyst

  Pharma Market Research. RESPONSIBILITIES:Extracting the data from world wide web using softwares Radian 6 and Sermo.Analysing the conversations going around the drugs from the data and tagging it as positive,negative and neutral.Reporting the conversation in the form of Pivots and Presentation to the clients.Implementation Strategy with Qualitative market research.; Neon Laboratories Limited

• 

  VHB Lifesciences Ltd

  Feb 2012 - Jun 2013

  Drug Regulatory Assistant in Regulatory Affairs

  Preparing the Checklist for required Documents according to the country guidelines.Interacting with all concerned departments (Production, QA, QC, R&D and projects) concerning the Regulatory submissions and Compliance.Coordination with different departments for ensuring timely delivery of dossiers.Reviewing the documents to meet compliance of Standards.Preparing dossiers for various ROW countries.Communication with customers regarding updates to information, covering all technical aspects.Maintain Access Database on products submitted with Various Authorities.Archival of Queries [Customer query and Agency queries] Minder weergeven

• 

  Tata Consultancy Services

  Apr 2014 - Jan 2023

  Domain Responsibilities1. Perform Submission publishing activities for the different regions with applicable dossier formats. 2. Perform the required activities within established timelines that are of high quality with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes.3. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists.4. Utilize current electronic document management and publishing tools to prepare submission-ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions;5. QC electronic and paper submissions to ensure compliance with company and agency requirements;6. Provide component-level publishing support to ensure submission components conform to e-submission standards (e.g., templates, scanning, indexing);7. Maintain effective interactions with all publishing contributors and responsible RA professional, to ensure timely delivery of dossier components taking into consideration special requirements and needs;8. Maintain open and timely communication; and Participate on special projects and process improvement initiatives Minder weergeven

  • Team Lead for Global Regulatory Submission Publishing for a Pharma Client

    Jun 2021 - Jan 2023

  • Submission Publishing for a Pharma Client

    Apr 2014 - Jun 2021
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  Freyr Solutions

  Jan 2023 - now

  Team Lead