Regulatory Officer

5 days ago

Sucat Metro Manila, Philippines Oxford Distributions, Inc. Full time ₱900,000 - ₱1,200,000 per year
Qualification:
  • Bachelor's degree in Food Technology or related field.
  • At least 1 yr of hands-on experience in FDA product registration and LTO process.
  • Strong knowledge of FDA Circulars, AO and e-portal submission system.
  • Familiarity with product classification, risk categories and labeling standards.
  • Excellent documentation, communication, and organizational skills.
  • Certification in HACCP, GMP, Halal is an advantage.
Job Summary:
  • Prepare and submit LTO applications (initial, renewal, or variation) through the FDA ePortal.
  • Compile and submit complete CPR dossiers in compliance with FDA AO and relevant regulations.
  • Coordinate with third-party laboratories for product testing (e.g., microbiological, physico-chemical).
  • Monitor application status via FDA eServices and respond to FDA queries or deficiencies.
  • Maintain an updated compliance tracker for LTO and CPR expirations, renewals, and ongoing applications.
  • Ensure that product labels, inserts, and promotional materials comply with FDA regulations.
  • Liaise with regulatory bodies such as BAI (for animal products), DA, or DOH as needed.
  • Assist in FDA inspections, audits, and document control for quality management

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