Claverra Vicky Livanza

Experience

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  Martina Berto

  Apr 2016 - Sept 2017

  Packaging Development
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  Nature Republic Inc

  Jan 2018 - Dec 2021

  Regulatory Affairs

  1. Handle registration for Cosmetic Products2. Negotiating with Regulatory authorities (BPOM or Indonesian FDA/ Ministry of Health)3. Prepare registration documents 4. Maintain a strong relationship with stakeholders5. Submit adverse event (MESKOS) and distribution record every 6 months to health authorities as required6. Compiling and Maintaining Product Information Files

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  Rumah Sakit Husada

  Jan 2020 - Feb 2020

  Apoteker (Internship)
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  PERIPERA

  Dec 2021 - Apr 2024

  Technical Responsible (PJT) & Regulatory Affairs Specialist

  1. Handle registration for Cosmetic Products2. Negotiating with Regulatory authorities (BPOM or Indonesian FDA/ Ministry of Health)3. Prepare and review registration documents 4. Ensuring compliance with regulations set by BPOM and Ministry of Health in Indonesia5. Maintain a strong relationship with stakeholders6. Keep abreast of Cosmetic product requirements7. Handle for product complaints (quality and for adverse effects of cosmetics)8. Submit adverse event (MESKOS) and distribution record every 6 months to health authorities as required9. Review product label artwork & advertising materials including Bahasa Indonesia translations10. Compiling and Maintaining Product Information Files Show less

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  Meiyume

  May 2024 - now

  Technical Responsible - Regulatory Affairs - Product Compliance

  Ensuring product complied with country regulation and meet the customer standard in terms of safety. Fully check the formulation complied with the regulation for destination country and register the product before launch to the market. Request new product launching registration document.Responsible for product information files of new product according to Indonesia regulation or customer requirement.Check for products (including formulation, ingredients, packaging, labelling)Raw material document controlMaintain the regulatory database of global/local and customer regulation in cosmeticsFollow up postponed product updating notification/registration database Collect all notification and registration certificates from BPOM and MoHTake care of "Halal" certification process of the product Support all regulatory issues relevant from customer enquires such as: product's claim, ingredient list, CFS, document's legalization, etc.PSA for cosmetics, home care, and medical devicesSupport the PV implementation Production report to BPOM & MoH per semester Show less