Responsibilities:

• Preparing registration dossiers and documents for variation amendments, ensuring compliance with up-to-date regulations.
• Ensuring that all applications are registered, submitted, and approved within the timeline.
• Managing Thai FDA comments throughout the submission process and ensuring products obtain registration approval within the planned timeline.
• Maintaining full awareness of all regulatory activities, ensuring that project deadlines and performance standards for these projects are established and met.
• Submitting the company's advertising and promotional materials to comply with all relevant internal policies and Thai FDA regulations within the timeline.
• Updating and renewing the company's license.
• Handling all reports related to TFDA, e.g., annual sales and import reports.
• Handling all consumer complaints and substandard cases from all channels and reporting them to headquarters.
• Supporting the supply chain for customs clearance, e.g., COA translation.
• Preparing product knowledge documents and presentations for participants from private and chain drug stores as requested by the marketing team.
• Presenting selling points for all company products.
• Preparing gift sets for all participants.
• Performing other related duties as required.

Qualifications:

• Bachelor's Degree in Pharmacy is required.
• More than 2 years of experience in drug regulatory affairs (RA).
• Fair command of English.
• Able to work Monday to Friday near BTS Ploenchit or Chit Lom.