Basic Info

Alaa badr

9 years

Cairo, Egypt

Bachelor's Degree

Experienced

Work Experience

Associate regulatory affairs manager at Central adminstration for Pharmaceutical affairs

Experience Details

Associate regulatory affairs manager

Pharmaceutical

Experienced (Non-Manager)

N/A


Company Details

Central adminstration for Pharmaceutical affairs

Cairo, Egypt

501-1000 employees

Pharmaceuticals

N/A

May 2007 to present (10 years 7 months)
Associate regulatory affairs manager at Central adminstration for Pharmaceutical affairs

Experience Details

Associate regulatory affairs manager

Pharmaceutical

Experienced (Non-Manager)

-For registration department :
*i worked at dietary supplment department
i was responsible for revising the soft file content & check al the company papers , then preparing the files for entering the scientific committee .
writing the committee decision letters to the companies.
*i worked at cosmetics department revising the soft file & hard file of the products ( local.toll.imported.under license).
revising the vartiations documents of the product.
revising the appeals of the companies..then preparing the committee and release the letters & registration lisence to the companies.
*i worked at the hard file section in human drug department revising hard files documents and follow up the technical committee decisions.
relesing the transfer letters as pharmacology,stability,variations to the companies.
*i was the senior of the bioequivalence committee revising all the data before submitting to committee : bioequivalence studies , companies & centers appeals , licensing centers issues and inspection issues.
releasing the committee decision letters to the companies & letters.
navigate & surfing the internet for the new informations and updated guidelines.
*i worked in multipharma as associate regulatory affairs manager for human drugs, biologicals,cosmetics products,importation and custome release.
*in the monitoring custome release department i'm responsible for deduction and lot release for cosmetics ,human drug , biologicals products and raw materials .


Company Details

Central adminstration for Pharmaceutical affairs

Cairo, Egypt

101-500 employees

Pharmaceuticals

www.eda.mohp.gov.com

May 2007 to present (10 years 7 months)

Education

pharmacist in pharmaceutical studies

Education Details

pharmacist

pharmaceutical studies

Cairo University, Egypt

B / Very Good / 75 - 85%

N/A

N/A

Cairo University
2001 - 2006
pharmacist in pharmaceutical

Education Details

pharmacist

pharmaceutical

Faculty of Pharmacy Cairo University, Egypt

B / Very Good / 75 - 85%

N/A

N/A

Faculty of Pharmacy Cairo University
2001 - 2006
High School - Thanaweya Amma

High School Details

Thanaweya Amma

EL Makrizy Language School

Egypt

2001

A / Excellent / 85 -100%

N/A

EL Makrizy Language School
2001

Training and Courses

Training/Course Details

ctd common technical dossier

Apr 2013

future university

N/A

Training/Course Details

analysis

Aug 2006

nodcar

Training in differents departments in nodcar as microbiology.analysis.cognosy

Training/Course Details

analysis

Aug 2006

nodcar

Training in differents departments in nodcar as microbiology.analysis.cognosy

Training/Course Details

clinical pharmacy course

Sep 2006

cairo university

N/A

This profile is not updated!
Last update more than 5 months ago.

Jobseeker photo

Profile Skills and Keywords

AnalysisArabicAssociate Regulatory Affairs ManagerClinical Pharmacy CourseCreativeCtd Common Technical DossierEnglishHard WorkerInnovativeInternet SurfingLogisticsOrganized PlacesOrganizerPersistentPharmaceuticalPharmaceutical Custome ReleasePharmaceutical Regulatory AffairsPharmaceutical StudiesPharmaceuticals

Self-assesed Skills

Languages

Arabic

Arabic

: Fluent

: Fluent

: Fluent

: Fluent

English

English

: Fluent

: Fluent

: Fluent

: Fluent

Fields of Expertise

Pharmaceutical regulatory affairs

Pharmaceutical regulatory affairs

: Expert

: Extreme - I love it!

:

More than 7 years

pharmaceutical custome release

pharmaceutical custome release

: Expert

: Extreme - I love it!

:

Less than 1 year

Key Skills

Hard worker, Creative, Organizer, Innovative, Persistent

Online Presence

allaa84abadr@gmail.com

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