ALEXA REBANCOS

I’m a dedicated and detail-oriented Regulatory Affairs professional with hands-on experience in biologicals and vaccines. I bring a strong background in regulatory submissions, quality agreements, and cross-functional collaboration, with a deep understanding of both local and international regulatory landscapes. My approach is solution-driven—I don’t just raise challenges; I bring well-thought-out proposals to the table

• Handles ACTD submissions marketed in the Philippines, Jordan, Algeria, Morocco, Tunisia, South Africa and Nigeria (Initial,Variation, FGMP, etc.) for Biological products
• Submits Named-Patient Basisapplications to HSA
• Collates and arrangesdocuments to be filed underForm E to be later on inspected by HAS
• Handles Quality Assurancetasks such as Temperature excursion.
• In constant communication with Principals 
• Handled submissions in all divisionof the FDA (Drug, Food, Cosmetics and Medical Device)
• Monitored the renewables of all certifications such as Licenseto Operate, Marketing Authorization, Certificate of Good Manufacturing Practice, and other certifications.
• Analyzed dossier provided by the head office/supplier to be submittedunder Monitored Release, OTC, or Prescription Initial Submission. (ASEAN & ICH Common Technical Dossier)
• Strategizes submissions in accordance with the list of priorities given by the Country Manager.
• Submits compliance such as variations, notifications, response letters, and alignment of packaging materials with the FDA's comments.