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Regulatory Affairs Executive

Job Title: Regulatory Affairs Executive
Contract Type: Permanent
Location: Bangkok
Industry:
Salary: THB 60,000 (Depend on Expricnce)
Reference: TH__002137
Contact Name: K.Atitaya (Sun)
Contact Email: Atitaya.Jaiyen@jac-recruitment.com
Job Published: July 10, 2019 11:05

Job Description

One of the world's leading pharmaceutical companies. They are looking for a Regulatory Affairs Executive to join their team in Thailand.

Job Descriptions:

  • 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 and product licenses
  • Review and approve advertising and promotional items to ensure regulatory compliance 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

Qualifications:

  • Male - Female, Age over 25 years old (THAI Nationality ONLY!)
  • Bachelor's Degree or higher in Pharmaceutical or equivalent in a health science field
  • A minimum of 2-3 years overall regulatory experience in the pharmaceutical industry
  • Deep experience from pharmaceutical industry from a regulatory affairs perspective
  • Good command of English and good computer literacy
  • Pharmacist license preferred

Location: BTS Area

Working hours: Mon – Fri / 9:00 AM. – 05:00 PM.

 

To apply for this job, click on the apply button or contact the consultant above directly.

(*Only shortlisted candidate will be contacted.)

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