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Regulatory Affairs Specialist (Thailand)

Location: Bangkok, Thailand
Position Type: Unfixed Term

Summary

To ensure regulatory compliance of the company by carrying out various pre-market and post market activities, including but not limited to application for import permits, product registrations, etc.

 

Responsibilities

  • Responsible for following and implementing local / country regulatory requirements for Thailand.
  • Manage product registration, change notifications and renewals, ensuring timely submissions.  Perform and maintain  product registration licenses and other regulatory licenses with Thai FDA and other relevant authorities.
  • To coordinate local testing with local authorities when required as a part of  local registrations requirements
  • Keeping up to date with regulatory watch process, updates on regulations and informing stakeholders on key impact. Support internal and external audits when applicable;
  • Develop, maintain and implement the regulatory procedures when applicable;
  • Ensure that the product, packaging and artwork of the current and new products comply with the regulation requirements;
  • Perform other regulatory activities as per requirements from Thai authorities to ensure the company’s regulatory compliance. 
  • Perform change impact assessment based on Thai regulations.       

 

Requirements

  • Bachelor degree in related field or higher
  • At least 3 years working experience in regulatory affairs in Thailand
  • Good organizational and communication skills. Fluenct in Thai and English to communicate with key stakeholders locally and in the region
  • Computer literacy including Microsoft Office
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