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Regulatory affairs coordinator

Location:
Cairo, Cairo Governorate, Egypt
Posted:
January 14, 2020

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Resume:

Sherif Mahmoud Hussein

CONTACT DETAILS

MOBILE: +2-011********– HOME: +2-02-235*****

E-MAIL: adbaq7@r.postjobfree.com ADDRESS: Apt no. 7 - 3

th

Floor –

Omran st. – from st. no. 77 - Maadi, Cairo, Egypt. Career Objective:

Seeking a challenging position as a regulatory affairs specialist where I can utilize my full potential, enhance my experience & develop my career in such field. PERSONAL DETAILS

DOB: 17/11/1991

EDUCATION

High School Diploma: National Thanaweya Amma – 2011 El-Helal El-Ahmar Language School, Maadi, Cairo – biology Section Cairo University – (graduated)

B.SC. of pharmaceutical science – Faculty of pharmacy – Cairo University – July 2016 Degree: Very good

WORK EXPERIENCES

Works as regulatory affairs coordinator at Pfizer global supply Cairo site (2019-Present) Job description:-

- Preparing the documents and CTD sections required for renewal, re-registration and variations for locally manufactured products

- Liaise between the MoH and PGS Cairo site.

- Planning and monitoring all upcoming and ongoing variations and renewals.

- Responsible for preparing the documents required for any audit or inspection on the factory by either CAPA or NODCAR, as well as accompanying the inspector through his/her visit.

Works as regional regulatory lead associate at Pfizer (2018-2019) Job description:-

- Preparing the documents and CTD sections required for renewal, re-registration and variations for all Levant markets.

- The key link between the global leads and the in country leads.

- Planning and monitoring all upcoming and ongoing variations and renewals.

Worked on art work remediation project for Africa and Middle East region at Pfizer (2018) Job description:-

- Comparing the supplied art work with registered art work to find out the discrepancies.

- Communicate with the in country leads to solve out these discrepancies and reach 100% compliant art work.

- Communicate with the global team to prepare the required documents

- Communicate with supply team and in site team to collect any required data.

Worked as regulatory scientific office specialist at Sanofi (2016) Job description:-

- Preparing the documents and CTD sections required for renewal, re-registration and variations for Egypt and Sudan markets.

- Responsible for preparing the documents required for any audit or inspection on the factory by either CAPA or NODCAR, as well as accompany the inspector through his/her visit.

Works as private physics teacher for secondary stage (2011-present) TRAINING EXPERIENCES

Trained at Pfizer factory in the production area (summer 2014)

Trained at community pharmacy (summer 2012, summer 2013 and summer 2015)

Trained as medical representative at Origin company (2013)

Public relation member at MOIC “student activity” at faculty of economics and political science Cairo university (2012-2013)

Quality control basics

LANGUAGE SKILLS

Arabic: Native Language

English: Very Good (both in written and spoken)

French : Fair

COMPUTER SKILLS

Microsoft PowerPoint – Microsoft Word – Microsoft Excel : Very Good COURSES

Business administration at the AUC (2015 - 2017)

- Interpersonal skills

- Organization behavior

- Business finance

- Human Resources

- Principles of marketing.



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