Regulatory Affairs Officer

20 hours ago


Metro Manila Philippines PHIL INTER PHARMA MANILA CO., LTD. Full time

Responsibilities

  • Prepare and compile regulatory dossiers in compliance with Food Supplement, ACTD, and National Guidelines for Philippine FDA submissions, including initial registrations, amendments, and variation applications.
  • Develop International CTD and ACTD dossiers for product registrations and renewals.
  • Monitors updates on pharmaceutical regulations from the FDA and other authorities.
  • Ensures quality compliance and timely submission of regulatory documents.
  • Maintains records for Dossier tracking and submission status.
  • Reports directly to the Dossier Team Leader and Head - Regulatory Affairs Manager.
Job Qualifications and Skills
  • Must be a licensed/registered Pharmacist (RPh).
  • Preferably with Regulatory Affairs experience; fresh graduates are welcome to apply.
  • Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook) and PDF tools.
  • Strong attention to detail.
  • Skilled in proofreading for grammar, spelling, and punctuation.
  • Able to work under pressure and meet tight deadlines.
  • Confident in reporting to higher management.
  • Demonstrates strong teamwork skills.
Benefits
  • Food, transportation, and communication (load) allowance
  • Health card
  • Sales incentive
  • Christmas bonus
  • License allowance
  • University tuition fee assistance (for eligible dependents)
  • Happy Friday (1-hour early leave every Friday)
  • Separation pay
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