Regulatory Affairs Officer

Curriculum Vitae

Magy Ezzat Nisr

Doctor of Pharmacy.

Mobile : +971-*********

Email : dr. **********@*****.***

PERSONAL

DATA:

Objective:

Education:

ELLECTIVES

COURSES

Experience:

Date of birth: 3th.Feb. 1990

Nationality: Egyptian.

Marital status: Married.

Driving License: U.A.E / EGYPT.

Hope to apply for the position in which, I will

be able to fully utilize of my skills and

qualifications at your company.

University : Sinai University

Faculty : pharmacy and pharmaceutical

Industries

Graduation year: 2012

General Average grade upon graduation:

( Good ) In the college

- Radiopharmaceutical

- Cosmetics preparation

• In Past:

Community Pharmacist :-

• At Pharmacy Medical Centre In RAK

• Medical Rib,Egypt, Aswan

• At El- EZABY pharmacy In Cairo, Egypt

In Details:-

- Ensuring that different treatments are compatible.

- Checking dosage and ensuring that medicines are correctly and safely supplied and labelled.

- Dispensing prescription medicines to the public.

- Keeping a register of controlled drugs for legal and stock control purposes.

- Liaising with doctors about prescriptions.

- Prescription of over-the-counter medicines.

- Counselling and advising the public on the treatment of minor ailments.

- Advising patients of any adverse side-effects of medicines or potential interactions with other medicines/treatments.

- Inventory of the drug stock.

- Arranging for the drug orders through Communication with the distributors.

Experience for both 1 year.

• Current Time: Work in Julphar (Gulf

Pharmaceutical Industry), especially in the

Regulatory Affairs Department in Ras Al

Khaimah,United Arab Emirates .,

In Details:-

I have experience four years in Regulatory Affairs Field For the following :

• I'm responsible of the preparation of the new registration & renewal dossiers as per the different Health Authorities Requirements.

• Preparation of CTD Files for Kurdistan, Iraq, Oman, GCC, Morocco, Uganda & Malawi. Also follow up of the

registration progress

• Of the product, manufacturing site in different countries.

• I was assigned as a leader of the group working on UAE

(CPPs Request),For different countries

• Preparation of the Registration Dossiers as per the current guidelines of the different Health Authorities and ensuring that the product submitted are complete properly formatted & comply with the latest regulations and is performed in accordance with the standard operating procedures in order to get the approval for the product registration in the shortest possible time.

• Studying scientific and legal documents, gathering, evaluating, organizing, managing and collating information in a variety of formats (CTD, eCTD, NeeS).

• Responsible for all registration, renewal,notification preparation in U.A.E for all products

• To coordinate with the Administration Dept. and follow up them to receive the required documents as soon as possible. To clarify :-

• In life cycle team: responsible

to Renewal files preparation in different countries (UAE, Oman, Bahrain, Syria,Jordan,Lebanon,Ethiopia, Sudan,Qatar, Cameroon & all countries GCC)

• Also in live cycle team responsible to Original CPPs Request preparation in different countries (Specific Countries).

• In Combination Team (RCC team): preparation New

registration dossiers for Iraq, Kurdistan, Malawi, Kuwait & Morocco.

• Also in In Combination Team (RCC team): preparation CTD File for Ethiopia, Uganda & Kuwait.

• Additional Requirements for Iraq & Oman

Experience 4 years.

Training

and

scientific

trips:

Certificate from Pfizer lectures about

Basic selling, Effective Presentation

&Leadership from 25th to 26th of July

2009.

Certificate from EZABY Pharmacies about

Accessories, Pharmaceutical

Preparation, Control of Asthma

Antibiotics, Diabetes Management from

1st to 31st of 2010

30 credit hours training course in Epico

pharmaceutical industries 2011.

Training & certificate from 57357

HOSPITAL about Clinical practice at

Oncology field.

Certificate from EGYPTIAN

PHARMACIST SYNDICATE in EPSF

about Clinical Package from 1st to 31st of

2009.

Certificate from EGYPTIAN

PHARMACIST SYNDICATE in EPSF

about Pharmacy role in follow up

patients with chronic diseases from 1st to

31st of 2009.

Certificate from D.S.P at 28 July 2009.

Course in General English_Pre-

Intermediate Level from the AMERICAN

UNIVERSITY in Cairo.

Certificate from Ministry of Health &

Population with Cooperation of Medical

Training Department of International

cultural center I.c.c about clinical

Practice for Pharmacists (clinical

pharmacology) from 5\7\2009 to

28\7\2009.

Certificate in Basic Life Support & First

Aid at July 06, 2011.

Other skills:

Language:

Reference

Computer Skills:

• Excellent user of searching through the

internet.

• Very good user of Microsoft office.

• Good knowledge about Photoshop.

• Certificate from the AMERICAN UNIVERSITY

gain (PowerPoint _Access_Excel) from july8 to

July 30, 2009.

Personal Skills:

• Have a driving license.

• Active, responsible and Ability to work

Outside normal working hours.

• Good analytic skills & orienting solutions.

• Ability to work in team work.

• Very good presentation skills.

Arabic is the mother language.

English (speak well and read/write with basic

competence)

Available upon Request.

In the view of C.V I hope you will consider and let me serve for your organization that I can prove

myself to be the right choice.

Contact this candidate