Regulatory Pharmacist

Qualification

• Must be a licensed/registered Pharmacist

• Fresh graduates are welcome
• Preferably with more than 2-years of work experience in the field of Regulatory on Prescription Medicines
• Knows how to operate Microsoft Office (MS Word, Excel, PowerPoint, Outlook), PDF (Nitro Pro, Adobe etc).
• With Good English communication skills.
• Highly self-motivated, goal oriented and committed in pursuing long term career.

• With High Comprehension Skills
• Exceptionally well organized and strong work ethics

Job Description

• Responsible in ensuring the correctness and compliance of the documents per FDA Guidelines for the Initial Applications and Biologicals Drug Applications upon submission to FDA to merit an approval and secure a Certificate of Product Registration.
• Ensures that approval and Certificate of Product Registration will be given for the Initial Registration of Prescription Medicines, Medical Device Initials and Cosmetic Notifications.
• Responsible for renewal and revalidation of Principal Certificate of Product Registration and Certificate of Listing of Identical Product and ensure that the documents are overflowing with quality to secure the approval from FDA.
• Responsible for variation/amendment applications of Certificate of Listing of Identical Product and Principal Certificate of Product Registration.