Title:  Junior Executive, Regulatory Affairs

Job Summary

Execute the company quality assurance (QA), safety, health & environmental (SHE) and registration (REG) policies and standards, guarantee the regulatory compliance to local and international laws and regulations

General Responsibilities

• Support client to prepare document and sample for registration and renewal on time. Eg. Assessment, dossier and sample preparation, Khmer application, upload into the system,...etc
• Review and manage the registration document and samples based on our SOP and KPI achievement
• Communicate with MoH (DDF) to get the process done smoothly. Eg, registration follow up, monitoring and regulatory approval.
• Support client for post marketing and supplement regulation such as the variation, advertising and KH PI.
• Review and approve on KH PI before process printing.
• Update the product master list, report and ensure that the list is up to date
• Monthly report to client on status of their product registration
• Others task assign by Manager

Functional Skills and Knowledge

• Drive self-learning and improvement in the area of Regulatory Affairs and DKSH behaviors as part of continuous learning

Education

• Bachelor of Pharmacy or related disciplines