Regulatory Pharmacist

7 days ago


Manila, National Capital Region, Philippines AMB HK Enterprises Inc. Full time

Job Qualifications:

Candidate must possess at least Bachelor's/College Degree in PharmacyLicensed PharmacistAt least 1 year experience in regulatory affairs.Knowledge in ASEAN Medical Devices DirectiveExperience in medical device registration is an advantage. Duties and Responsibilities: Review of the medical devices dossier and documents based on ASEAN Medical Device Directive.Checking and approval of artworks for medical devices.Strategize and plan course of action for the whole regulatory pathway aligned with the timeline.Updating the standard operating procedures for the assigned tasks.Facilitate FDA inspections as needed.Other applications for pharmaceuticals. Privileges: In-house training for the registrations of pharmaceuticals, medical devices, food supplements and cosmetics as per ASEAN, FDA and other guidelines.Attend FDA seminars and trainings.

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