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.
- 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.
- 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