Sharon NG

Regulatory Affairs Specialist at Sam Chun Dang Pharm. Co. Ltd
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Contact Information
us****@****om
(386) 825-5501
Location
Seoul, South Korea, KR
Languages
  • English Native or bilingual proficiency
  • Chinese Native or bilingual proficiency
  • Korean Full professional proficiency
  • French Elementary proficiency
  • Mandarin Full professional proficiency
  • Japanese Elementary proficiency

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Credentials

  • Microsoft Word Expert 2016
    Microsoft
    Apr, 2021
    - Nov, 2024

Experience

  • Sam Chun Dang Pharm. Co. Ltd
    • 1 - 100 Employee
    • Regulatory Affairs Specialist
      • Jan 2023 - Present

      • Person-in-charge of FDA BLA, EMA and Health Canada regulatory submissions for Eylea Biosimilar • Person-in-charge of FDA BLA, EMA and Health Canada regulatory submissions for Eylea Biosimilar

  • LUCA AICELL
    • Gyeonggi, South Korea
    • Regulatory Affairs/Quality Assurance (RA/QA) Associate
      • Dec 2021 - Jan 2023

      • Person-in-charge of Global Regulatory Affairs (IVD & MD) including FDA EUA, CE MDR, MFDS and Australia TGA •Set up the regulatory strategy for CE MDR, compile the Technical Documentations and successfully received the CE mark in Jan 2023 • Monitor and analyse the trend of regulatory guidelines, time needed and difficulty of each registration to establish an implemented regulatory strategy plan • Provide regulatory and technical advice to relevant departments from product development to post-market stage • Build, compile and submit regulatory applications and supporting documentations to competent authorities, including analytical performance test protocols and reports, clinical study protocol and labelling documents • Develop, review and maintain SOPs as required to ensure compliance to relevant legislations and KGMP Show less

  • RAPIGEN INC
    • South Korea
    • Medical Device
    • 1 - 100 Employee
    • Regulatory Affairs Associate
      • Jun 2021 - Dec 2021

      • File the WHO PQ & EUL, FDA EUA and other American and African countries’ IVD regulatory submissions • Collaborate with PATH and FIND to conduct a clinical trial in Senegal and Indonesia • Conduct gap analyses for updated guidelines to identify incompetency between the products and the guidelines, and provide suggestions to overcome the discrepancies • Prepare and submit regulatory applications to competent authorities by reviewing the supporting documentations and composing the Product Dossiers • Liaise with the competent authorities through written communications and videoconferences Show less

  • Yonsei University Korean Language Institute
    • Seoul, South Korea
    • Korean-English Translator
      • Dec 2020 - Feb 2021

      - Perform various translation duties from Korean into English, including school notices, Korean Proficiency Test questions and emails - Develop new online Korean learning materials - Perform various translation duties from Korean into English, including school notices, Korean Proficiency Test questions and emails - Develop new online Korean learning materials

Education

  • The Chinese University of Hong Kong
    Bachelor's degree, Biochemistry
    2014 - 2018
  • Yonsei University Korean Language Institute
    Korean Language and Literature, Level 5
    2020 - 2021
  • SKH Tsang Shiu Tim Secondary School
    HKDSE
    2008 - 2014

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