Registration Specialist

Main Job Duties:

• Prepare the whole required documents stated in the checklist to submit any soft or hard file.
• Communication with Importing & Purchasing department to obtain valid, sealed and signed C.O.A. & GMP certifications.
• Send appointment request to CAPA for hard file & request inquiry (in case of new product & re-registration).
• Submit & follow regularly any soft or hard files that were submitted to CAPA.
• Receive any notes from CAPA requiring any modification and updating of information concerning the company products.
• Revision of any received stability study file from Q. C. department together with the addition of all the required registration documents.
• Send e-mails to Stability Committee in CAPA for appointments to submit stability files on the due dates.
• Submit & follow up stability files till receiving the approval from CAPA.
• Submit & follow up any documents concerning variation to CAPA.
• Submit & follow up any documents concerning Prices of our products.
• Search for all approved sites from CAPA upon which registration department can depend to prepare the required pamphlets of the company products.
• Follow up any warning or precautions stated by CAPA & re-write the pamphlets.
• Submit & follow up the required pamphlet & correct any comments till receiving the approved one.
• Create updated sheets of our products in the different stages of registration upon request from other departments.
• Revise all “change control documents” to organize and regulate the production process according the new approvals.