Regulatory Affairs Executive

• Prepare, check, compile and submit GMP clearance and the company's products registration dossiers including drugs, functional foods/ foods supplement, medical devices, cosmetics, etc. (including Initial dossiers/ renewal dossiers/ supplementary dossiers/ variation dossiers).
• Responsible for ensuring that the dossiers are correct and accurate according to the regulations of the Pharmaceutical Law and current legal regulations of the FDA.
• Work with manufacturers and customers to provide documents and dossiers related to registration.
• Ensure the submission and approval of all delivered drugs within the optimal time schedule.
• Handle issues related to the Company's drug registration dossiers.
• Make periodic/ad hoc work reports as required by management.
• Manage documentation and track/follow up regulatory submissions and approvals.
• Coordinate with internal departments to ensure compliance with regulatory requirements.
• Update new regulations, circulars, requirements or laws to manager.
• In charge for product labeling, packaging, and promotional materials compliance
• Build good relationship, company image with FDA departments.
• Achieve target set up as per KPIs which decide by time to time.

Qualifications

At least 1 year experience in the same position.