Regulatory Specialist

3 weeks ago


Pasig, National Capital Region, Philippines Total Nutrition Corporation Full time

Job description

Regulatory Specialist

  1. Food Registrations (FDA) – review and preparation of documents and actual sample for submission
    • Initial Applications
    • Renewal Applications
    • Reapplications (submissions with compliance)
  2. LTO (FDA) – communicate with front end staff regarding FDA concerns
    • Initial Applications
    • Renewal Applications
    • Variations (Notice of Change of Pharmacist, transfer of location)
    • CAPA (compliance during inspection)
  3. Attend meetings/seminars within and outside the organization as advised by the immediate superior
  4. Assist customers / inform product knowledge if needed

REQUIREMENTS / QUALIFICATIONS

  • Ability to work efficiently in a high-pressure, fast-paced, deadline-driven environment.
  • Good written and verbal communication skills.
  • Excellent people skills to interact with colleagues
  • Familiarity with FDA Guidelines
  • BS PHARMACY Graduate
  • Pharmacist's Licensure Exam Passer
  • At least 2 years Experience in Industry

Job Types: Full Time

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