Thu Vu Le

Experience

• 

  Unilever

  Aug 2013 - Feb 2014

  Regulatory Affairs Assistant

  Responsibilities:• Ensuring that a company's products comply with the regulations of the local Drug Administration Vietnam (DAV) of Ministry of Health. • Keeping abreast of international legislation, guidelines and customer practices and dealing with local authorities for the updated, common practices.• Liaising with, and making presentations to, regulatory authorities; negotiating with regulatory authorities for marketing authorization.

• 

  GSK

  Mar 2014 - Dec 2018

  Responsibilities:• Product RegistrationPrepare artwork drafts for regulatory submission (new products and variations) for Pharmaceuticals, Vaccines and Medical Device. Ensure that packaging components are initiated and approved to comply with the Cambodia & Laos registration requirement prior to submission.Initiate and approve artwork upon regulatory approval as per internal required timelines for all products, including safety changes to leaflet.• Product Compliance Ensure product regulatory compliance of the product (Pharmaceuticals, Vaccines and Medical Device) during the life cycle for the packaging components, specifications and registered details eg shelf life and storage• Regulatory Risk ManagementReview & Updating of risk register to ensure all risks are captured and appropriate mitigation plans are in place to minimize the risk to the business.Ensure up to date training completion of regulatory trainings and other mandatory GSK trainings• Artwork CoordinatorMaintain and manage all the artwork archives.• Other: Compliance lead, SOP champion and GSK systems champion. Show less

  • Area Regulatory Executive

    Jan 2017 - Dec 2018

  • Regulatory Affairs Manager

    Nov 2015 - Dec 2016

  • Regulatory Affairs Executive

    Mar 2014 - Nov 2015
• 

  Abbott

  Jun 2019 - Mar 2021

  Associate Regulatory Affairs Manager
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  Organon Asia Pacific

  Mar 2021 - now

  Regulatory Affairs Specialist