Role Description

This is a full-time, on-site role for a Regulatory Affairs Officer based in Melaka. The Regulatory Affairs Officer will be responsible for preparing, reviewing, and managing regulatory documentation, ensuring compliance with applicable regulations, and adhering to regulatory requirements. The role involves coordinating and submitting regulatory submissions and liaising with internal and external stakeholders to address regulatory affairs needs.

Qualifications

• Experience with Regulatory Documentation and preparation
• Knowledge of Regulatory Compliance and adherence to relevant legal standards
• Understanding of Regulatory Requirements and frameworks
• Proficiency in Regulatory Affairs and delivering regulatory solutions
• Experience in managing Regulatory Submissions and ensuring timeliness
• Strong organizational and communication skills
• Bachelor’s degree in Life Sciences, Regulatory Affairs, or relevant field
• Familiarity with clinical trials and supply chain processes is an advantage