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Work experience

Export business development Deputy Director & regulatory Adviser

from 08.2015 to 02.2017 (1 year 6 months)
Pharco Pharmaceutical Corporation, Egypt, Alexandria (Chemical industry, pharmaceuticals)

Responsible for worldwide Hepatitis Treatment medicines.
Keep in track established markets and their growth.
External projects management
Training of new candidates
Regulatory strategies and dossiers approval.

Export business development Manager & regulatory Advisor

from 07.2013 to 08.2015 (2 years 1 month)
Pharco Corporation (Amriya, Pharco, Pharco B, European Egyptian, SafePharma), Alexandria (Chemical industry, pharmaceuticals)

Chasing new opportunities and Penetration of new markets.
Establishing and managing the day-to-day business relationships and transactions with all agents.
Liaise between different companies and depts.
Responsible for Vertical and Horizontal Dev.
Export Sales follow up.
Lead transfer of supply chain production planning, logistics, and release testing to partners.
Regulatory Strategies.

Global regulatory affairs deputy manager

from 08.2009 to 07.2013 (3 years 11 months)
Pharco Corporation, Alexandria (Chemical industry, pharmaceuticals)

Handling all regulatory issues and preparing, reviewing and
compiling registration file of CTD, ANDA and WHO formatting for the submission.
Specialized in NeeS/ eCTD submission
Regulatory support for clinical and medical trials
(eg. bioequivalence, clinical trials phase III, post marketing surveillance, Pharmacovigilance…etc)
Extensive experience in CMC.
Team leading capabilities for over then 6 specialists.
Countries of specialty: CIS, GCC, Australia, Europe.

Global regulatory affairs deputy manager

from 08.2009 to 07.2013 (3 years 11 months)
Pharco Pharmaceutical Corporation, Egypt, Alexandria (Chemical industry, pharmaceuticals)

Handling all regulatory issues and preparing, reviewing and
compiling registration file of CTD, ANDA and WHO formatting for the submission.
Specialized in NeeS/ eCTD submission
Regulatory support for clinical and medical trials
(eg. bioequivalence, clinical trials phase III, post marketing surveillance, Pharmacovigilance…etc)
Extensive experience in CMC.
Team leading capabilities for over then 6 specialists.
Countries of specialty: CIS, GCC, Australia, Europe.

Global regulatory affairs manager Amriya Pharmaceutical Ind. Co

from 08.2008 to 08.2009 (1 year)
Amriya Pharmaceutical Ind.Co, Alexandria (Chemical industry, pharmaceuticals)

Handling all regulatory issues and preparing, reviewing and confirming registration dossiers.

Project manager

from 03.2008 to 08.2008 (5 months)
Generx Pharma for Pharmaceuticals and cosmetics, Alexandria (Chemical industry, pharmaceuticals)

Suggestion of new products, proceeding in product development and registration.
Managing purchasing issues

Regulatory affairs and development pharmacist

from 03.2007 to 03.2008 (1 year)
Medizen Pharma, Alexandria (Chemical industry, pharmaceuticals)

Reviewing, collecting all data for registration files to be submitted to Egyptian MOH.
Participating in formulation and development of new products
Preparing BPR of soft gelatin products
Drafting and formulation of inserts and leaflets (PIL).

Export sales and logistics manager

from 11.2005 to 03.2007 (1 year 4 months)
Amriya Pharmaceutical Ind., Alexandria (Chemical industry, pharmaceuticals)

Responsible or GCC countries, MENA countries and Francophone.
Liaison between different departments to insure optimum export activity.
Markets sales.
Communication.
Global marketing.
Tenders and regulatory worldwide market and
export performances for the specified Territory.

Export Specialist

from 04.2004 to 11.2005 (1 year 7 months)
Amriya Pharmaceutical Ind., Alexandria (Chemical industry, pharmaceuticals)

Regulatory affairs.
Tenders.
Logistics documentation
Global Sales.

Head of Pharmaceutical products in Microbiology department –Quality control directorate

from 01.2003 to 04.2004 (1 year 3 months)
Amriya Pharmaceutical Ind., Alexandria (Chemical industry, pharmaceuticals)

Microbiological quality control activities.

Part timer Medical representative

from 06.2002 to 06.2003 (1 year)
Ranbaxy Pharmaceuticals., Alexandria (Chemical industry, pharmaceuticals)

Education

Alexandria Faculty of Pharmacy, Egypt

B.sc of Pharmacy and pharmaceutical chemistry, Pharmacist, Alexandria, Egypt
Higher, from 1996 to 2001 (4 years 9 months)

•Diploma in the Arts of Exporting and logistics, qualifying as Export Expert year 2006 accredited by Foreign Trade Ministry, IMC and European Union.
•Marketing Diploma in the Basics of marketing, marketing skills, negotiation skills & selling skills Year 1999-2000 issued by AAST & AUC.
•Alliance Française (certificate of French language) year 1995 sorted by CCF (centre culturel Française).
•Training certificates in the field of NeeS / eCTD formatting.
•Trained by extedo for submission software.

Additional education and certificates

•Diploma in the Arts of Exporting and logistics, qualifying as Export Expert year 2006 accredited by Foreign Trade Ministry, IM

2006

Marketing Diploma in the Basics of marketing, marketing skills, negotiation skills & selling skills Year 1999-2000 issued by AAS

1999-2000

•Alliance Française (certificate of French language) year 1995 sorted by CCF (centre culturel Française).

1995

•Training certificates in the field of NeeS / eCTD formatting.

2000

Knowledge and skills

Language proficiencies

• English — advanced
• French — advanced

Additional information

Based on extensive experience in merged markets worldwide, regulatory systems, team leading and business development as well as industrial techniques in health care industry, I am capable to be a useful elements and added value for whom decide to knock this field and looking for effective business. Responsible for Hepatitis Programs and projects internationally.Trained to work with new sFDA and GCC regulations of pharmaceutical registration.
Trained to submit eCTD files using extedo software, Professionalism in CMC module.
Chasing new business Opportunities.
Extensive experience in generics' manufacturers' obstacles preventing export.
Problem solving.

Field of Specialty:
1-Lebanon
2-Francophone countries.
3-Gulf countries.
4-CIS countries.
5-UK.
6-South east Asia.
7-Latin America.