To ensure regulatory compliance of the company by carrying out various pre-market and post market activities, including but not limited to application for product registrations, change notification and renewals, etc.
Main Accountabilities
Ensuring the implementation of local / country regulatory requirements for Thailand.
Perform product registrations, change notifications and renewals, ensuring timely submissions. Perform and maintain product registration licenses and other regulatory licenses with Thai FDA and other relevant authorities.
Keeping up to date with regulatory watch process, updates on regulations and informing stakeholders on key impact.
Support internal and external audits when applicable.
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.
Support other regulatory tasks (in ASEAN region) on need basis.
Typical Studies-Experience, Skills And Qualifications
Bachelor's degree in related field or higher
At least > 3 years working experience in regulatory affairs in Thailand.
