Paphapit Namkong

- Import Operations & Compliance ◦ Review and approve Certificates of Analysis (COA) for importation and customs clearance. ◦ Ensure compliance with GDP (Good Distribution Practice) for imported products. ◦ Facilitate GMP clearance and manage documentation. - Regulatory Documentation & Coordination ◦ Coordinate with Regulatory Affairs (RA) and suppliers to obtain necessary documents for product registration, renewal, and other regulatory submissions. ◦ Coordinate the preparation of documents for regulatory submission of imported medical devices. - Sourcing & Reference Standards ◦ Manage existing import reference standards and source new reference standards as needed. - Cross-Functional Communication ◦ Liaise with internal teams including Medicine, Medical Equipment, Raw Materials, and Packaging to ensure alignment on documentation and import requirements. - Logistics Coordination ◦ Assist in facilitating shipments and ensuring timely delivery of imported goods.

- Train sales staff on product information and sales ethics. - Prepare teaching materials such as slides, manuals, etc. - Provide product information to customers over the phone (Drug Information Service). - Handle customer complaints.

- Ensured accuracy and completeness of informed consent form (ICF) for EC submission. - Submit documents to local EC websites for review and approval. - Review on-site files, subject’s binder, and medical records to ensure quality, adequacy and completeness of documentation. - Reconcile the content of the investigator site file with the trial master file during site monitoring visits. - Perform investigational product (IP) reconciliation and review storage. - Provide supporting activities including tracking and processing invoices to investigational sites, collecting and completing calibration certificate trackers.

Conduct an experiment to investigate the induction of cellular senescence on cancer cells by new drug candidate molecule.