Experience

PT. KKV INTERNATIONAL INDONESIA

• Indonesia
• Retail
• 100 - 200 Employee

• Regulatory Affairs Specialist

  • Jul 2023 - Present



MAHAKAM GROUP

• Indonesia
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Registration Supervisor

  • Mar 2022 - Jul 2023

  - Preparing products dossiers for drug products and health supplements registration according to ASEAN Common Technical Dossier (ACTD) format - Presenting registration documents to regulatory agencies/authorities for new products, product changes/variations, and Marketing Authorization renewals, including submitting bioequivalent study proposals for approval documents while carrying out any subsequent clarifications or negotiations necessary to obtain or maintaining Marketing Authorization in timely manner - Advising and assessing on legal and scientific restraints and requirements for marketed and new products - Controlling and managing the process of products' Marketing Authorization's information inputs to the Indonesian Ministry of Health's online database - Communicating with Contract Manufacturing Department and preparing the registration documents and dossiers for Contract Manufacturing needs in timely manner - Supervising the ongoing process of Change Requests that affected to the applied regulations - Supervising and controlling the process of Registration Department's administration staff's assignments Show less



PT Sydna Farma

• Jakarta, Indonesia

• Regulatory Affairs Pharmacist

  • Jul 2019 - Mar 2022

  - Preparing products dossiers for registration according to ASEAN Common Technical Dossier (ACTD) format - Presenting registration documents to regulatory agencies/authorities for new products, product changes/variations, and Marketing Authorization renewals, including submitting bioequivalent study proposals for approval documents while carrying out any subsequent clarifications or negotiations necessary to obtain or maintaining Marketing Authorization - Advising and assessing on legal and scientific restraints and requirements for marketed and new products - Communicating with licensor company for licensed products regarding legal or regulatory issues. - Assisting research and development team on product developments or changes. Show less



Apotek S3 Farma

• Indonesia

• Pharmacist

  • Oct 2018 - Jun 2019

  - Practicing as a community pharmacist. - performing managerial tasks for the drugstore - including stock management and purchasing - communicating with pharmaceutical and healthcare distributors - Practicing as a community pharmacist. - performing managerial tasks for the drugstore - including stock management and purchasing - communicating with pharmaceutical and healthcare distributors