On-site - Pasay No Exp Required Bachelor Full-time

Job Description

• Responsible for ensuring the correctness and compliance of the documents per FDA Guidelines for the Initial Applications and Biologicals Drug Applications upon submission to the FDA to merit approval and secure a Certificate of Product Registration.
• Ensures that approval and Certificate of Product Registration will be given for the Initial Registration of Food Initials, 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.
• Communicates Equivalence Evidence Study with the supplier, evaluates, and prepares for submission. Makes sure that the Bioequivalence Study Report meets the Criteria of ASEAN Guidelines, and Biowaiver Study/Comparativ...