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Опыт работы

Export business development Deputy Director & regulatory Adviser

с 08.2015 по 02.2017 (1 год 6 месяцев)
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

с 07.2013 по 08.2015 (2 года 1 месяц)
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

с 08.2009 по 07.2013 (3 года 11 месяцев)
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

с 08.2009 по 07.2013 (3 года 11 месяцев)
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

с 08.2008 по 08.2009 (1 год)
Amriya Pharmaceutical Ind.Co, Alexandria (Chemical industry, pharmaceuticals)

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

Project manager

с 03.2008 по 08.2008 (5 месяцев)
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

с 03.2007 по 03.2008 (1 год)
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

с 11.2005 по 03.2007 (1 год 4 месяца)
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

с 04.2004 по 11.2005 (1 год 7 месяцев)
Amriya Pharmaceutical Ind., Alexandria (Chemical industry, pharmaceuticals)

Regulatory affairs.
Tenders.
Logistics documentation
Global Sales.

Head of Pharmaceutical products in Microbiology department –Quality control directorate

с 01.2003 по 04.2004 (1 год 3 месяца)
Amriya Pharmaceutical Ind., Alexandria (Chemical industry, pharmaceuticals)

Microbiological quality control activities.

Part timer Medical representative

с 06.2002 по 06.2003 (1 год)
Ranbaxy Pharmaceuticals., Alexandria (Chemical industry, pharmaceuticals)

Образование

Alexandria Faculty of Pharmacy, Egypt

B.sc of Pharmacy and pharmaceutical chemistry, Pharmacist, Alexandria, Egypt
Высшее, с 1996 по 2001 (4 года 9 месяцев)

•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.

Дополнительное образование и сертификаты

•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

Знания и навыки

Знание языков

• Английский — продвинутый
• Французский — продвинутый

Дополнительная информация

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.