Chuyên viên RA

Purpose of Function

• Support & perform regulatory tasks as assigned by RA Manager in full compliance with local and international regulations.

Job Responsibility

• Preparation of all materials / regulatory documentation needed for submission, license renewal and annual registration according to regulatory requirements of various regions or to commercial partners as requested.
• Liaise with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review as requested.
• Maintain regulatory files / database in good chronological order.
• Maintain system for tracking changes in documents submitted to agencies or partners.
• Registration of intellectual property, product trademark, business registration.
• Recommend changes, review and approval for manufacturing procedures, labeling / advertising / marketing materials and clinical protocol and process/test methods changes for regulatory requirements and laws compliance.
• Provide the regulatory reviews of customer complaints and define the regulatory reportability.
• Perform coordination in participating in activities such as audits, regulatory agency inspections, or customer complaint handling.
• Actively participate in research of regulatory issues and dissemination regulatory information to relevent departments.
• Participate in developing standard operating procedures of Regulatory Affairs department.
• Protect operations by keeping information confidential.
• Perform other tasks and assignments which to be assigned by RA manager.