Regulatory Affairs Officer
5 days ago
Regulatory Affairs Officer – Dossier Team
Phil Inter Pharma Co., Ltd.
Job Description:
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.
Job Type: Full-time
Pay: Php26, Php32,000.00 per month
Benefits:
- Company Christmas gift
- Health insurance
Work Location: In person
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