Basic Info

Khaled Amin

5 years

Giza, Egypt

Master's Degree

Experienced

Work Experience

Front Office Team Leader for Biological Products Registration at Central Administration of Pharmaceutical Affairs

Experience Details

Front Office Team Leader for Biological Products Registration

Administration, Medical/Healthcare, Operations/Management

Manager

•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.


Company Details

Central Administration of Pharmaceutical Affairs

Cairo, Egypt

501-1000 employees

Government, Medical Devices and Supplies, Pharmaceuticals

www.eda.mohp.gov.eg

Feb 2014 to present (2 years 10 months)
Biological Registration specialist at Central Administration of Pharmaceutical Affairs

Experience Details

Biological Registration specialist

Administration, Medical/Healthcare, Operations/Management

Entry Level

•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.


Company Details

Central Administration of Pharmaceutical Affairs

Cairo, Egypt

501-1000 employees

Government, Medical Devices and Supplies, Pharmaceuticals

www.eda.mohp.gov.eg

Jan 2012 to Jan 2014 (2 years)
Biocides Registration specialist at Central Administration of Pharmaceutical Affairs

Experience Details

Biocides Registration specialist

Administration

Entry Level

- 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.


Company Details

Central Administration of Pharmaceutical Affairs

Cairo, Egypt

501-1000 employees

Government, Medical Devices and Supplies

N/A

Sep 2011 to Jan 2012 (4 months)
Community Pharmacist at Ali & Ali pharmacy – Mohandssen Branch

Experience Details

Community Pharmacist

Medical/Healthcare

Experienced (Non-Manager)

- Dispensing prescriptions for both in and outpatients.
- Compounding pharmaceutical preparations.
- Ensure that every customer receive friendly, knowledgeable, and efficient service.


Company Details

Ali & Ali pharmacy – Mohandssen Branch

Giza, Egypt

1-10 employees

Pharmaceuticals

N/A

Sep 2009 to Sep 2011 (2 years)

Achievements


•Member of the team created Biosimilar registration Guideline.
•Creating & issuing the first Second Brand Guideline in Egypt, which reduce the time & documents required for second brand registration, increase availability of second brand products in local market and helping local Pharmaceutical companies gaining technology transfer from multi-national Pharmaceutical companies.
•Creating and introducing Company Profile System, which contains all legal-company documents, which decreases the documentations needed in core registration dossier (Module I).
•Improving similar box system by converting it to electronic based, which facilitate the process and reduce time required to receiving, reviewing and issuing similar box status.
•Implemented an improved process of reviewing, evaluating & handling of submit applications, which results to increase the number of registered products by 300%.


•Member of the team created Fast Track Guideline, which in advance support the applicants in getting licenses for vaccines, lifesaving products and assuring the availability of this product in Egyptian market rapidly.


Education

MBA in Management

Education Details

MBA

Management

Cairo University, Egypt

Not specified

N/A

N/A

Cairo University
2014 - 2016
Bachelor's Degree in Pharmaceutical Sciences

Education Details

Bachelor's Degree

Pharmaceutical Sciences

Faculty of Pharmacy Cairo University, Egypt

Not specified

N/A

N/A

Faculty of Pharmacy Cairo University
2005 - 2009

Certifications

ICDL
Jan 2011

Certificate details

ICDL

Jan 2011

N/A

N/A

N/A

Ministry of Communications and Information Technology (MCIT)

N/A

Certificate details

ATEFL (Academic Test of English as a Foreign Languauge)

Jan 2015

N/A

N/A

N/A

Cairo University

N/A

Training and Courses

Training/Course Details

Scientific, Clincal & Regulatory considration on LMWHs, Biological Products & Biosimilars

Dec 2014

ANSM - France

N/A

Training/Course Details

Biosimilar workshop

Nov 2012

CAPA Biological department head & NORCB - Cairo

N/A

Training/Course Details

Egyptian Biosimilar Guideline workshop

Feb 2013

CAPA Biological department head & NORCB - Cairo

N/A

Training/Course Details

Global view of Requirements, Manufacture and Control of Biosimilar products

Aug 2012

ERA Consulting Group - UK

N/A

Training/Course Details

CTD format overview & description of different modules

Apr 2012

Science forum for research studies & consultancy - Jordan

N/A

Training/Course Details

Project Management Professional (PMP) preparation course

Jan 2016

Al-Darayn Academy

N/A

This profile is not updated!
Last update more than 3 months ago.

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Profile Skills and Keywords

ATEFL (Academic Test Of English As A Foreign Languauge)Able To Motivate And Lead Others In A Team Environment.Able To Prioritize Tasks And Workloads In Order Of Importance.AdministrationAn Ability To Build Rapport And Trust Quickly With Work Colleagues.ArabicBiocides Registration SpecialistBiological Registration SpecialistBiosimilar WorkshopCTD Format Overview & Description Of Different ModulesCommunity PharmacistEgyptian Biosimilar Guideline WorkshopEnglishFront Office Team Leader For Biological Products RegistrationGlobal View Of Requirements, Manufacture And Control Of Biosimilar ProductsGovernmentICDLMBAManagementMedicalMedical Devices And SuppliesPharmaceutical SciencesPharmaceuticalsProject Management Professional (PMP) Preparation CourseProven Ability To Manage Through Others.Scientific, Clincal & Regulatory Considration On LMWHs, Biological Products & BiosimilarsStrong Decision Making And Problem Solving Skills.

Self-assesed Skills

Languages

Arabic

Arabic

: Fluent

: Fluent

: Fluent

: Fluent

English

English

: Fluent

: Fluent

: Fluent

: Advanced

Fields of Expertise

Proven ability to manage through others.

Proven ability to manage through others.

: Expert

: Extreme - I love it!

:

1-3 years

Strong decision making and problem solving skills.

Strong decision making and problem solving skills.

: Advanced

: High

:

3-5 years

Able to motivate and lead others in a team environment.

Able to motivate and lead others in a team environment.

: Advanced

: Extreme - I love it!

:

1-3 years

An ability to build rapport and trust quickly with work colleagues.

An ability to build rapport and trust quickly with work colleagues.

: Advanced

: Extreme - I love it!

:

1-3 years

Able to prioritize tasks and workloads in order of importance.

Able to prioritize tasks and workloads in order of importance.

: Advanced

: Extreme - I love it!

:

3-5 years

Online Presence

https://eg.linkedin.com/in/kamin1

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