Management Health
Resume:
Curriculum Vitae
Heba Alla M. Hassan
Address *** ***** *,*****, ***** investment park 2,Dubai, UAE Mobile: +971-**-*******
Email: *********@*****.***
OBJECTIVE:
I am seeking to gain a position of regulatory affairs. My skill set includes problem solving, time management, decision making, communication and organizational skills. I thrive on challenge and I am flexible and adaptable. In addition, the commitment, enthusiasm and determination to succeed that I bring to every task ensure that I am an asset in the workplace
EDUCATION
March 2008 Ministry of Health License, UAE.
1999 - 2004 Faculty of pharmacy,Cairo, University,Egypt A grade very good honors
May 1999 Orouba Language School, Cairo, Egypt.
High School Certificate/A grade 98.4%
2 3Pages
WORK EXPERIENCE
Jan- 2012- up to date
- Regional Strategist - Regulatory Affairs – MENA
Pfizer Middle East, Media City,Dubai
Job Responsibility :
Maintain, compliant and strategize Registration of products, supporting project for product re-Sourcing & post-approvals variations. Assigned Markets : Gulf,LEVANT,North Africa
Product : Pharmaceutical & Biological
- Job Duties:
1. Set a submission strategy for execution of lifecycle submissions associated to management of CMC changes originating at manufacturing sites or market demand toward maximizing efficiency, quality and rate of submission approvals by BoH . 2. Support Project Planning, phasing, executions and asses all risk that may occur during execution, and set mitigation plan if required,
3. Communicating stakeholders for the project, organizing kick of meetings for the project and follow up meetings.
4. Ensure all Regulatory requirements provided in accordance to regional HA guidelines to have ready submission dossier on time.
5. Ensure Company systems (RRM, PDM, RCCM) are in
compliance with the product status and regional regulatory guidelines.
6. Provide regional/local management of lifecycle submissions in markets under responsibility, including: Market Application amendments, variations, renewals, supplemental submissions. 7. Coordinate with the Regulatory Process & Systems Support and Publishing team for the generation of the submission ready components required to support lifecycle submissions. 8. Ensure that the CMC change management electronic systems are updated and maintained in alignment with the regulatory information submitted/approved externally by a Board of Health or internally by the appropriate functional area that facilitate PGS (Manufacturer sites implementation )at the right time .
9. Manage timely responses to Board of Health questions resulting from lifecycle submissions in markets under responsibility.
10. Assemble lifecycle submissions for markets under responsibility and coordinate with PCO’s for timely and effective submission of changes to the Boards of Health.
11. Compliance with Department and Company Standard Operating Procedures (SOP's) relevant to the position. 12. Interaction with plants, PCO’s, and Division personnel in 3 3Pages
relation to regional regulatory conformance activities. October 2010 till Dec- 2011
- Regulatory affair Manager Alkopharma Middle East, Dubai
- Job Duties:
1. Communicate with Ministry of Health acknowledging the company in France all guidelines & checklist for registration of pharmaceutical products in GCC & MENA, arranging appointment for submission of registration dossiers, ensuring that the registration process are preformed in time.
2. Arrange with the registration department in France to send all registration files, samples & requirement in time, scheduling the priority of work, acknowledging the due time for renewal & submission of the requirement either for Minor variation or new registration.
3. Report generation as updating registration status for the products registered, due for renewal & Minor Variation for each country. 4. Coordination and follow-up with our Local Agency in GCC & MENA to fulfill registration requirements.
5. Drafting business communications in English & Arabic. 6. Administration Skills to assist in the company’s operation & management activity, Information handling & Data management. 7. Arrange Good Documentation system for easy access of any information.
8. Preparing SOPs and organize training for warehouse team how to deal with medicine.
October 2008- September 2010
- Pharmacist in Charge & Regulatory affair specialist Al Baker Drug store, Dubai
- Job Duties:
1. Follow up all warehouse operations, insuring that’s it complies with international standard operation procedure as
2. clearing and forwarding of shipment
3. checking picking, dispatch goods to the customers, 4. Quality Assurance for temperature control in the ware house for room temperature and fridge items &
5. Quarantine and destruction of expired damage goods. 6. Modify SOPs and trained warehouse team how to deal with medicine
7. Coordination and follow-up with our principal companies 8. Communicate with government departments. As Ministry of Health, Municipality & customs to fulfill their needs. 9. Report generation (Intake Register, updating registration status ….) 10. Drafting business communications.
11. Administration Skills to assist in the company’s operation & management activity
4 3Pages
12. Information handling & Data management.
August 2007- October 2008
- Executive Assistant at EIPICO (Egyptian International Pharmaceutical Company) Gulf Office, Pharmatrade Dubai
- Job Duties:
1. Report generation
Monthly report calculating target, achievement, growth MTD & YTD,
Daily Visit report for the Medical Rep.,
Sales Forecast Report,
Registration Report for five gulf countries,arranging registration dossiers for product new registration & renewal for Ministry of health submission
2. Prepare & Revise the registration files to be submitted to MOH 3. Receive & reply on corresponding.
4. Follow up the shipment procedure & Invoices
5. Preparing for Scientific Trainings & Meetings with the Team 6. Administration Skills to assist in the company’s operation & management activity
7. Information handling & Data management.
Aug 2004 - Feb.2006.
- Pharmacist at NODCAR (National Organization for Drug Control and Research) Cairo, Egypt.
- Job Duties:
1. Identification and Assay of drug active ingredient. 2. Approve the Imported drugs (e.g. Hormones, Vitamins 3. Make Research for new ways drug analysis using UV & HPLC Instruments and titration.
4. In the department of QC (Quality Control) identify and Assay of drug active ingredient using UV & HPLC Instruments and titration. SKILLS
Computing: I am proficient in using MS Word, including Excel. I also have basic competence in PowerPoint
Languages: I speak Arabic and English fluently.
Additional Information
5 3Pages
Married,I have a daughter & a Son.
My birth date 27/4/1982 Cairo, Egypt.
My hobbies are swimming, Reading, scientific journals in connection with my course and for pleasure, is my passion. I also enjoy keeping fit through swimming and a weekly trip to the gym.
I hold a full, clean driving license
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