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Pharmaceutical & Medical Services
21 Mar 2017
Job Opportunity : Regulatory Affair Specialist (80K)
Position
Regulatory Affair Specialist
Our Client
One of The Top 5 Global Pharmaceuticals Company
Location
Bangkok
Report to
Regulatory Affairs Associate Director

Responsibilities

  • Assist in regulatory issues including product registration submission, variation application, advertising company licenses in accordance with Thai Food and Drug Administration (FDA) and Developing of Livestock Department.
  • Interacts with regulatory agency to expedite approval of pending registration.
  • Assist in reviewing regulatory documents and materials such as package inserts, labels and other packages.
  • Support other regulatory issues such as COA translation, goods release, SOPs, etc.
  • Maintain regulatory database and report regularly.
  • Support Regulatory Affairs Leader and regulatory team in preparing purchase request, expenditures, support internal communication work, meeting, send sample testing, etc.
  • Prepare documents for batch release application, sample license, raw material permission, variation packaging per timeline, to submit at one stop service and Thai FDA.
  • Handle adverse reaction case and report to Thai FDA and Global.
  • Review and verify packaging material and if applicable, revise packaging by using PDF program per Thai FDA requirement for registration and importation.   

Qualifications

  • Bachelor’s Degree in Pharmacy (Pharmaceutical science).  
  • 4-7 year experiences in regulatory administration or documentation is preferable.
  • Good command in English both written and spoken.
  • Outstanding skills in MS Word, MS Excel, Internet, E-mail, PDF, typing both Thai & English