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Nisa Nopporn

Nisa Nopporn

Research Techinician (Immunology Department, Faculty of Medicine)

Followers of Nisa Nopporn547 followers
location of Nisa NoppornBangkok, Bangkok City, Thailand

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  • Timeline

  • About me

    Associate Regulatory Affairs Manager

  • Education

    • Cambridge Seminars College

      2010 - 2011
      Certificate of Pre-Master Degree in Biomedical Sciences Biomedical Sciences, General

      Activities and Societies: Intensive preparations for postgraduate admission - Intensive study to meet the postgraduate degree language proficiency requirements- Preparation for postgraduate study socially and academically- Revised the academic writing and speaking

    • Queen Mary, U. of London

      2011 - 2012
      Master of Science (MSc) Forensic Medical Sciences

      Activities and Societies: Forensic Medicine Legal Aspects, Forensic Medical Sciences, Coroner's Court visits, Coroner's Court mortuary visits and post-mortem observation - Clinical aspects of forensic medicine: - Forensic pathology: - Legal and ethical issues relevant to forensic medicine and science:- Forensic toxicology:- Forensic identification: - Research project: Difficulties in Forensic Toxicological Interpretation: Drug Pharmacology and Post-Mortem Redistribution

    • Chulalongkorn University

      2005 - 2009
      Bachelor of Science (BSc) Medical Technology

      Activities and Societies: Tradition CU-TU Football staffs, University Games - Joined Registration team in CU Academic Fair 2005- Member of CU-TU Football Game 2006- Member of CU-TU Football Game 2007- Senior academic counseler in Academic CU Academic Fair 2008- Led the Comminucation and Association team during Medical Technology University Games, 2008- Intensive internship at Chacherngsao Hospital 2008-2009

  • Experience

    • Chulalongkorn University

      Apr 2009 - Apr 2010
      Research Techinician (Immunology Department, Faculty of Medicine)

      - Performed clinical researches from inception to completion;- Coordinated with external research institutes;- Instructed and assisted internship students on research procedures- Ensured all tools and machines were in good conditions, inclusively sufficient chemical supplies at all time.

    • S&J International Enterprises PCL

      Feb 2013 - Sept 2016
      Product Efficacy Evaluator

      - Set up and evaluate finished good safety and efficiencies;- Coordinated with other research institutes or companies in performing a test;- Designed suitable techniques and prepared protocols following ICH and GCP procedures;- Recruited, selected and motivated potential applicants throughout the study;- Maintained study data and related information with confidentiality practice;- Provided trainings of scientific tools/equipment to research technician.

    • Johnson & Johnson

      Oct 2016 - Jul 2018
      Regulatory Affair Specialist (Medical Devices)

      - Ensure all company medical devices meet legislative requirements;- Collate, organize and evaluate information in a variety of formats;- Ensure compliance with regulations set by the Medical Device Control Division, the Food and Drug Administration (FDA);- Keep up-to-date with changes in regulatory legislation and guidelines;- Offer advice about company practices and systems;- Liaise and negotiate with regulatory authorities;- Providing advice about regulations to stakeholders;- Fully support company’s business strategies. Show less

    • BD

      Aug 2018 - now

      - Leading regulatory strategies aligning with business strategy- Leading regulation sensing and advocating- Strategic partnering with business and supply chain in removing obstacles, hence minimizing potential gaps or risks - Product Registrations - Keep up-to-date to Thailand and Other Asia Medical Devices Regulations- Company and Regulatory Compliance- Support business/market plans

      • Associate Regulatory Affairs Manager

        Jan 2024 - now

      • Senior Regulatory Affair Business Partner

        Jan 2023 - Dec 2023

      • Regulatory Affairs Executive

        May 2019 - Dec 2022

      • Regulatory Affairs & Compliance Executive

        Aug 2018 - Apr 2019

  • Licenses & Certifications

    • ISO/IEC17025: 2005 (1 Day Course)

      ISO International Organization for Standardization
      Feb 2014

  • Honors & Awards

    • Awarded to Nisa Nopporn
      ISO/IEC 17025: 2005 S&J International Enterprises PCL Feb 2014 - Attended the ISO-IEC 17025: 2005 (1-day course) conference and passed the examination