
Khaled Amin
MBA
Giza, EgyptWork Experience
Front Office Team Leader for Biological Products RegistrationFull Time
Central Administration of Pharmaceutical Affairs
Feb 2014 - Present -11 yrs, 5 months
Egypt , Cairo
- 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
Central Administration of Pharmaceutical Affairs
Jan 2012 - Jan 2014 -2 yrs
Egypt , Cairo
- 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
Central Administration of Pharmaceutical Affairs
Sep 2011 - Jan 2012 -4 months
Egypt , Cairo
- 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.
Community PharmacistFull Time
Ali & Ali pharmacy – Mohandssen Branch
Sep 2009 - Sep 2011 -2 yrs
Egypt , Giza
- Job Details:- Dispensing prescriptions for both in and outpatients. - Compounding pharmaceutical preparations. - Ensure that every customer receive friendly, knowledgeable, and efficient service.
Education
MBA in Management
Cairo University (CU)Jan 2014 - Jan 2016 - 2 yr
Bachelor's Degree in Pharmaceutical Sciences
Cairo University (CU)Jan 2005 - Jan 2009 - 4 yr
Skills
Languages
Arabic
FluentEnglish
Advanced
Training & Certifications
Project Management Professional (PMP) preparation course
Al-Darayn Academy·2015ATEFL (Academic Test of English as a Foreign Languauge)
Cairo University·2014Scientific, Clincal & Regulatory considration on LMWHs, Biological Products & Biosimilars
ANSM - France·2014Egyptian Biosimilar Guideline workshop
CAPA Biological department head & NORCB - Cairo·2013Biosimilar workshop
CAPA Biological department head & NORCB - Cairo·2012Global view of Requirements, Manufacture and Control of Biosimilar products
ERA Consulting Group - UK·2012CTD format overview & description of different modules
Science forum for research studies & consultancy - Jordan·2012ICDL
Ministry of Communications and Information Technology (MCIT)·2010