Khaled Amin

Front Office Team Leader for Biological Products RegistrationFull Time

• Job Details:•Manage & Monitor all functions performed by the team including the following: 1.Reviewing request inquiry before issuing box approval. 2.Final review of registration files before issuing registration/renewal license. 3.Reviewing all letters, assessment reports & Technical committee appeals done by the team. 4.Reviewing and approving biological products pack labels. 5.Follow up of the committees’ decisions implementation •Member of Imported Products Stability Committee, responsible for revising and approving stability studies of imported products. •Preparation of guidelines, Standard Operating Procedures & work instructions. •Organizing the work flow and assigning different tasks to the biological registration team. •Supervise and assist the front office team in their performance. •Provides appropriate regulatory advice and support to manufacturers. •Identify areas for improvement within daily functions & procedures, and anticipates new or changing regulatory requirements to improve these processes.

Biological Registration specialistFull Time

• Job Details:•Carrying out the Registration & Re-registration hard files of Vaccines, Sera, Blood Products, Insulin and different Biological Products of all companies in Egypt. •Drug registration hard file recipient reviewer for imported and local biological medicinal products for human use. •Make assessment reports for Biological products submitted for registration. •Follow up the approvals issued from different committees and departments. •Responsible for evaluating registration dossier (Stability, Pricing, Scientific, Pharmacology, Pharmacovigilance center, NORCB). •Preparing data & approvals for the registration dossier that will be submitted to the technical committee. •Prepare the final technical appeal.

Biocides Registration specialistFull Time

• Job Details:- Biocides registration soft and hard file recipient reviewer for imported and local products. - Make assessment reports for Biocides products submitted for registration. - Follow up the approvals issued from scientific committee & NODCAR. - Preparing data & approvals for the registration dossier that will be submitted to the technical committee.