Overview

• Salary

  70,000 THB ~ 100,000 THB

• Industry

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

• Job Description

  - Liaise with the FDA and regulatory consultant(s) 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 strategy for submissions, including regulatory timelines, during the planning phase for new Products based on regulatory expertise with regulations & processes.
  - Review technical dossier of new Products and prepare additional documents where necessary.
  - In-charge with the 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 andproduct licenses.
  - Review and approve advertising and promotional items to ensure regulatorycompliance. And submit to FDA.- Build and maintain relationships with key regulatory officials to influence regulators to achieve positive outcomes for product approvals or industry advantages.
  - Keep updated with FDA regulations and organizational structure and potential changes that will impact the business environment and communicate appropriately to involved or parties.
  - Researching and implementing new upcoming GDP regulation. For medical device.