Regulatory Affairs Specialist – Medical Devices / Pharma

Bangkok / UP TO 70K

Our client is a French pharmaceutical and healthcare company that has been established for over 50 years. The business boasts a strong presence in SEA with Thailand being a major emerging market for them that has grown substantially over the past 5 years. They are now seeking an experienced Regulatory Affairs professional to join their global organization.

The RA/QA Manager will report to the Regional Regulatory Affairs Manager in Singapore and the Thailand Country Manager. The successful candidate will be required to fulfil the following duties and responsibilities:

  • Perform import permit, product license registrations and other regulatory licenses with Thai FDA and other authorities via getting support from corporate functions and liaise with Thai FDA and other authorities to coordinate local testing when required for the registrations;
  • Local regulations monitor, regulatory intelligence and business impact analysis;
  • Support external audit 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.

Qualifications:

  • Qualified to degree level in Pharmaceutical Science or a related subject.
  • 3 + years of experience in a Regulatory Affairs role within a multinational pharmaceutical organization. Medical Device / IVD experience is a plus.
  • Good relationships with local government bodies in Thailand.
  • Very good English communication abilities (written and spoken).

This company is offering excellent career development opportunities with the added responsibility of coordinating directly with government authorities.

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