Your Mission

Regulatory Affairs and Quality Assurance

• Ensure company operations comply with applicable regulatory requirements, including FDA Philippines regulations and other relevant government standards.
• Prepare, compile, and submit regulatory dossiers and applications (registrations, notifications, variations, and reports) to the FDA Philippines in accordance with regulatory timelines and company requirements.
• Manage post‑market surveillance activities, including monitoring and reporting of complaints, adverse events, CAPA, FSCA, and product recalls until proper closure and documentation.
• Support and maintain the ISO 9001:2015 Quality Management System, including participation in Internal Quality Audits (IQA), preparation of Corrective Action Reports (CAR), process documentation, and contribution to Management Review activities.
• Serve as the liaison between regulatory authorities and internal departments, responding to ...