RA Specialist - Thailand

Primary Purpose and Overall Objective of the Job:

• 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.
• Good organizational and communication skills
• Computer literacy including Microsoft Office
• Well versed in English and Thai.