Regulatory Affairs Department Manager

Responsibilities

• Process for all MOPH related Licenses in a timely manner.
• Coordinate for the renewal and updating of Licenses.
• Process for product registration in a timely manner.
• Ensure that technical specification and text amendments are updated in registration file.
• Review packaging artwork for text and regulatory compliance.
• Coordinate with authority for acquiring necessary permits, purchasing of controlled substance, witnessing the destruction of controlled substance, and submitting reports to Authority as required.
• Coordinate with authority for the approval and inspection of plant design layout change or improvement.
• Prepare necessary technical file for Export or Import Registration and arrange required Regulatory documents.
• Organize the preparation of monthly, triannual, and annual reports to Authority, as well as other reports as per regulation.
• Monitor monthly status report.
• Communicate effectively with other managers and customer principals for the updated status of product registration and regulatory change situation.
• Perform other duties as assigned by superiors.