
Regulatory Affairs Officer
3 weeks ago
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.
- 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.
- 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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