
Regulatory Pharmacist
7 days ago
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.
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