Overview

• Salary

  40,000 THB ~ 50,000 THB

• Industry

  Manufacturing(Other), Manufacturing(Cosmetics/Healthcare), Manufacturing(Pharmaceutical/Medical Equipment)

• Job Description

  - Liaise with local National Regulatory Agency (Thailand Food and Drug Agency) on matters pertaining to regulatory activities, licenses, and permits for new and existing products (products include drugs, medical devices, food products and cosmetics)
  - Recommend the best regulatory strategies for submissions, including regulatory timelines, during the planning phase for new products based on regulatory expertise with regulations and processes
  - Review technical dossiers of new products and prepare additional documents where necessary
  - In-charge of timely approval and renewal of product licenses, company licenses, pre-and-post approval variations, permits and other applications
  - Handle post-marketing activities and yearly reporting requirements of company and product licenses
  - Provide appropriate solutions for compliance issues
  - Review and approve advertising and promotional items to ensure regulatory compliance
  - Build and maintain relationships with key regulatory officials to influence regulators to achieve positive outcomes for product approvals or industry advantages
  - Keep updated with local National Regulatory Agency (Thailand Food and Drug Agency) regulations and organizational structure and potential changes that will impact the business environment and communicate appropriately to involved or parties
  - Maintain a current awareness of regulatory requirements for the marketing of medicinal products in Thailand and general legislation and guideline