Regulatory Pharmacist - Quezon City

Job Qualifications:

• Candidate must possess at least Bachelor's/College Degree in Pharmacy
• Licensed Pharmacist
• At least 1 year experience in regulatory affairs.
• Knowledge in ASEAN Medical Devices Directive
• Experience 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.