Regulatory Affairs Specialist (Thailand)

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