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Regulatory Officer

2 months ago

Metro Manila, Philippines JTC Group of Companies Full time

Job Description:

  • Bachelor of Science in Pharmacist
  • Submission of initial, renewal, and variation applications for license of Operate with food and Drug Administration
  • Securing the certificate of product notification, certificate of Medical Device Notification/Registration of Food and Drug Administration for cosmetic and medical device products
  • Renewal of company accreditation and registration with Bureau of Customs
  • Updating of Company information with InterCommerce every renewal of accreditation with Bureau of Customs
  • Responds to FDA whenever a notice of Non-compliance/ Notice of Submission of Product Label is received; Preparation of Corrective Action and Preventive Action Plan, Explanation Letter
  • Collects, review and keeping of product dossiers
  • Modification of product label in adherence to FDA requirements; Securing that each Product has the assigned modified sticker label
  • Attends to inspections conducted by government agencies such FDA, DOH
  • Keeping up to date with government regulations pertaining to product registration, importation and other related matters
  • Updates the product tracker, request of payment for applications and responsible for liquidation
  • Preparation of purchase order for cosmetics and medical device, checking of invoices
  • Participates to seminars in relation to job function
  • Willing to be assigned in Ortigas Pasig City