Chatcha Na Nongkhai

- Prepared and reviewed regulatory submissions with a focus on detailed documentation and GMP clearance for Thai FDA approval. - Negotiated with regulatory authorities to solve issues and speed up the registration process. - Served as the Local Contact Person for Pharmacovigilance (LCPPV), ensuring compliance with local pharmacovigilance regulations and maintaining oversight of the local PV system. - Reviewed and overseed Individual Case Safety Reports (ICSRs) and other pharmacovigilance documents to ensure regulatory compliance. - Advised on product classification to ensure accurate regulatory pathway determination. - Interpreted Thai FDA regulations and provided strategic regulatory guidance to internal teams.

- Managed the preparation and compilation of regulatory submissions that secured approval from the Thai FDA - Communicated with regulatory authorities to address queries, concerns, and provide additional information - Ensured product compliance with regulatory requirements established by relevant authorities such as the FDA, EMA, and other regional regulatory bodies - Classified products according to regulatory guidelines to identify appropriate regulatory pathways and requirements - Monitored and kept abreast of changes in regulations, guidelines, and industry standards - Assisted with inspections conducted by regulatory agencies, contributing to obtaining licenses for various health products - Translated complex regulations into clear and concise procedures, bridging the gap between technical regulations and practical application - Monitored and tracked submission timelines and milestones to ensure the timely completion of regulatory activities - Participated in regulatory authority meetings and conference

- Dispended medications as prescribed by physicians and other healthcare practitioner - Instructed customer on how and when to take prescribed medications

- Submitted the application and ensured compliance with regulations set by the FDA - Kept up to date with changes in regulatory legislation and guidelines - Prepared submissions of licence variations and renewals to strict deadlines - Monitored and set timelines for licence variations and renewal approvals - Reviewed and approved product data and other submission documentation prior to submission to the FDA or other regulatory agency - Prepared submissions for health products advertisements - Reviewed and approved product labels and summary of product characteristics - Amended or additionally submitted the relevant documents - Negotiated with regulatory authorities for marketing authorisation - Advised scientists and manufacturers on regulatory requirements

Herbal Products Division - Assessed documents dossier - Prepared the assessment reports - Prepared some of information for National List of Essential Drugs A.D.1999 (List of Herbal Medicine Products)

Analytical Laboratory Services Pharmaceutical intelligence Unit Prachote Plengwittaya

- Updated international status change of overseas - Revised SOP of product registration - Prepared the product quality review