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Regulatory affairs manager

Location:
Cairo, Cairo Governorate, Egypt
Posted:
January 25, 2017

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Resume:

Yasmine Hosni Ahmed Omar

* ****** ******* ****** –Heliopolis-Cairo

Home Phone: 034253507

Mobile: 012********

email: acyg56@r.postjobfree.com

OBJECTIVE

Aiming to work in a well-reputed enterprise where I can use and develop my academic background, experience and personal qualifications to achieve the company’s goals and enhance my technical career in the field of Pharmacy. SKILLS

Language skills:-

Arabic mother tongue.

Fluent English

Fluent French.

Computer skills:-

Microsoft Windows

Microsoft Office

EDUCATION

1995-1999 University Of Alexandria Alexandria, Egypt

- B.S. Faculty of Pharmacy

- Graduation grade: Very good.

1981-1994 Institution Sainte-Jeanne Antide Alexandria,Egypt EXPERIENCE

6/2015 to present European Egyptian Pharmaceutical Industries Working as Export regulatory affairs manager for Pharco corporation pharmaceutical companies.

- Keep up to date with international legislation and guidelines in all countries to which corporation companies are exporting pharmaceutical products.

- Collect and evaluate scientific data that has been researched and issued by different corporation companies departments.

- Develop and organize complete CTD registration dossier including clear arguments and explanations to be submitted for new product registration or license renewal.

- Prepare submissions of license variations and renewals to strict deadlines.

-Written and oral communication with responsible agents in different countries in order to follow-up registration dossiers submission and to prepare appropriate reply for any inquiry.

- Team leading and time management for achieving department target. 10/2013 – 5/2015 European Egyptian Pharmaceutical Industries Working as Regulatory affairs deputy manager

- Manage and execute all registration related activities for different types of pharmaceutical products(drugs,dietary supplements,cosmetics and nutritional products).

-Follow-up contracts and requirements necessary for toll products registration procedures.

- Team leading for execution of different registration dossiers by providing the project team with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning.

- Maintain contact with regulatory authorities and company headquarters.

- Generate periodic reports for the updated status of company products.

- Prepare and translate products insert leaflets from scientific references.

- Organize approval for packaging material artwork. 9/2006- 9/2013 PharaoniaPharmaceuticals

Working as Regulatory affairs pharmacist

-Prepare registration files including forms and requests originating from government agencies.

-Update licensing and collect information on registration instructions and regulation.

-Maintain and update Standard Operating Procedures concerning packaging materials artwork.

-Maintain and update relevant documents to ensure compliance with ministry of health guidelines.

-Prepare pharmaceutical products export files for registration in different countries.

8/2002- 8/2006 Private pharmacy

Working as Pharmacist

OTHER SKILLS

Hard worker, have good time management skills and able to work under pressure.

TRAINING COURSES

CTD training courses

INTERESTS

Reading,walking and music.

ACHIEVEMENTS

-Elected to assist external audit for Pharco corporation manufacturing sites conducted by Francophone inspectors.

-Successful registration of antiviral product in Egypt ministry of health as CTD format ahead of schedule.

-Trained executives pharmacists.

-Provided regulatory advice to different departments and transformed relationship with regulatory affairs department into collaboration, respect and understanding.



Contact this candidate