Pharma Regulatory affairs section Head
Resume:
CV
Address:Sheben Al-Qanater, Al
Qalyubiyah, Egypt
Mobile: (002) 010********
Email: *****************@*****.***
**************@*******.***
Mahmoud Mohamed Ali Mansour
Objective
Seeking a job in a professional and dynamic
organization where I have chance to apply my
skills and acquire knowledge along with the
right tools to increase the present value of my
organization and consequently myself.
Experience
May 2017 - Present
DBK pharmaceutical industries company
Export Department
Regulatory Affairs Section Head
Follow –up & contact with our different agents in different countries
Contact with different Departments (R&D, Registration, Packaging, QA, QC and pharmacovigillance) for preparing Files and any further requirements from our Agents to complete the data required.
Preparing & submitting Files in CTD format & in Non-CTD formats to be submitting in eCTD program according to the guidelines of each country.
Make a database for the different products & its status with preparing periodical reports for it.
May 2010 – April 2017
Sigmatec pharmaceutical industries company
Registration following up Unit.
Regulatory Affairs Unit Head (Registration & Exportation)
Follow-up the different Systems of registration from M.O.H (Ministry of Health), and preparing & reviewing Inquiry requests & Applications for the different products).
Preparing & reviewing registration files of different products sticking to the last updated regulations from M.O.H before its submission.
Follow –up the Registration status of the different products in different registration systems (products with different Dosage forms, Cosmotics, Food Supplement).
Contact with different Departments (PDL, Methodology, Stability, Packaging, QA, QC and pharmacovigillance) for preparing Files and any further M.O.H requirements of the products Under registration & following up any changes required for the registered products
Plan and coordinate documentation/data for submission to M.O.H in CTD Format
Preparation of Files for Exportation in CTD format.
Preparation of files for re-registration products.
Prepare files for the products need bioequivalence & Comparative invitro dissolution studies & contact with the Approved companies preparing these studies & Follow –up these studies with it.
Make a database for the different products & its status with preparing periodical reports for it.
January 2009 – April 2010
Femto trade company
Sales Department.
Sales Representative
Make the prices offers for the company products from catalogues & websites of our suppliers & write daily & weekly reports for the customers visiting ( pharmaceutical industries,Reasearch centers,water companies,Food industries companies,petrolium companies )
Follow-up with our customers for Technical & Finanichial offers for our products.
Follow-up of tenders and practices put forward a day and buy their own notebooks conditions and preparation of financial and technical files and attend her meetings.
Follow-up with our outside suppliers by e-mails & Fax.
Follow-up of supply to customers on time.
Use the job tools (telephone and computer) effectively.
Achieve assigned sales target.
Communicate positively with all customers.
Work as part of a team & Achieve assigned tasks and meet deadlines. August 2007– August 2008
Hyma plastic-Hyma foam Company
Quality Department.
Quality Observer
Review daily order processing for each machine compared to be produced on the production line.
Matching the physical conditions and specifications of raw materials within each product on each machine to be confirmed with the processing order.
Follow-up of the production process for each machine on the production line with the technicians.
Conduct the necessary tests for each product in terms of tensile strength and printing in the Central lab.
Determination of manufacturing defects for each machine and processed and reported the case of defects to the production engineer, processing and isolation of non-conformity of the product.
Writing the manufacturing processes in the special book of daily shift. Courses
Sept. 2011 Implementation of Common Technical
Document (CTD), Modules of CTD – non-eCTD –
eCTD – preparation of CTD and eCTD.
At Sigmatec pharmaceutical industries company
Aug 08-Nov 08 Basic Business Skills Acquisition
(BBSA) Cairo, Egypt Sponsored by the Future
Generation Foundation (FGF)
Training
Developed Language provided by Berlitz
Developed Computer Skills provided by West wood co.
Enhanced Presentation & Project Development Skills
Acquired Basic Business Skills including: Marketing, Sales, Banking, Accounting, Business
Correspondence and Report Writing.
Acquired Computer Skills including: Word, Excel, Power Point, Access, Windows, Outlook, Internet,
IT.
Soft Skills :
Communication, Leadership, Management,
Presentation, Negotiation, Decision Making
- Acquired Language Skills:
Native language Arabic & Very Good command of both written and spoken English.
Nov 02, 2008 - Nov 10, 2008 Gradate Resources Program (GRP) sponsored by Future Generation Foundation (FGF) included : Dale Carnegie seminar (DCS) provided by Dale Carnegie Training co. Covered the following modules :
Effective Communications and Human Relations.
Code of ethics.
Sales Advantage- Negotiation.
Cold Calling and How to Build New Customers.
May 8, 2006 – May 22, 2006 Practical Training at Microbiology Dept. provided by National Research
Center
Covered the following :
Preparation of Microbiological media.
The effect of different antibiotics on different types of bacteria colonies on different types of media.
About aware of bacteriology, viruology and Zonotic diseases.
Education
2003-2007 Cairo University Cairo, Egypt
Faculty of Science, chemistry/zoology Dept.
Degree: Bachelor of Science
Grade: very good
2015-2016 Banha University
Faculty of Veterinary medicine, Biochemistry Dept.
Post graduate Degree: Diploma Clinical Biochemistry
Grade: very good
Personal Information
Date of Birth: 10/14/1985
Marital Status: Married
Military Status: Exempted
Passport No: Valid ( A06518514 )
Skills
Reactivity
Adaptability
Perfect communication skills - Team spirit
Interests Internet, Art, Painting, Reading, Chess, Football and Traveling References furnished upon request
Contact this candidate