Omnia Elshewi
Dubai
Overview
12
12
years of professional experience
Work History
PV Associate
Bioscript Inc
06.2023 - 06.2024
- Managed the collection, processing, and reporting of adverse events (AEs) and reconciliation reports
- Accountable for recognizing, triaging, and reporting as per the program or manufacturer requirements
- Maintained high compliance standards regarding reporting timelines, quality of reporting, and responding to inquiries from stakeholders
- Conducted pharmacovigilance compliance activities
Regulatory Affairs Specialist & Tenders Coordinator
Ibn Al Haytham Medical Co
02.2018 - 02.2021
- Prepared and submitted the dossier electronically according to the e-CTD structure, in accordance with the country guidance documents
- Archived all the submitted dossier copies properly to ensure compliance with the company SOPs
- Generated strategic plan by determining priorities and objectives on monthly basis through conducted meetings with our partner companies and different cross-functional departments
- Obtained approvals for registration of different sorts of products for example, a wide range of ophthalmic products for Bausch and Lomb, several biological products for Sandoz, and multi vaccines for serum institute in India
- First in the market to register home kit- pregnancy test by blood sampling
- Facilitated all companies' tenders, bids and RFQs and was able to win many hospitals tenders
Regulatory Affairs Associate
Ibn Sina Medical Co
01.2017 - 01.2018
- Approved many new pharmaceutical products for many multinational companies like Roche, Novartis, AstraZeneca, Jansen, Sanofi Aventis
- Accomplished and approved fast track review list for urgent drugs which were needed by the market
- Submitted different types of dossiers (new product submission, minor variations, product classification, renewal of registered products
- Organized and maintained all files related to regulatory actions
- Evaluated changes to documents submitted to determine the need for amendments
- Ensured all products meet legislative requirements and maintained consistent and efficient submission preparation processes
- Accelerated time to submission and time to approval and Maximize efficiency, performance, and productivity
Pharmacist
National Blood Transfusion Center
01.2012 - 01.2015
- Analyzed blood samples for the detection of infectious diseases
- Dispensed blood bags & organize shipments
- Trained the newly hired pharmacists
Education
Regulatory Affairs Graduate Certificate -
Humber College
Toronto, ON09.2023
Bachelor's Degree - Pharmacy Science
Cairo University
Cairo, Egypt05.2012
Skills
- Excellent planning and organizing skills to ensure successful submissions and compliance with regulations
- Able to prioritize tasks and manage multiple projects simultaneously to meet deadlines
- Skilled in building constructive relationships with internal and external stakeholders
- Highly passionate, detail-oriented and disciplined to take ownership of all responsibilities
- Excellent communication, analytical, and documentation skills
- Proficiency in Microsoft office programs: Excel, word, PowerPoint, and Microsoft Teams
Languages
English & Arabic
Courses and Trainings
- Health Care Legislation, Regulations and Guideline
- Product Development – Premarket & CMC
- Management of Local and Global regulatory Submission
- Medical Devices
- Provincial Formularies and Reimbursement Policy
- Clinical pharmacy course- American board of pharmacotherapy
- Pharmacovigilance
- Clinical pharmacy training- Cancer children hospital
Timeline
PV Associate
Bioscript Inc
06.2023 - 06.2024
Regulatory Affairs Specialist & Tenders Coordinator
Ibn Al Haytham Medical Co
02.2018 - 02.2021
Regulatory Affairs Associate
Ibn Sina Medical Co
01.2017 - 01.2018
Pharmacist
National Blood Transfusion Center
01.2012 - 01.2015
Bachelor's Degree - Pharmacy Science
Cairo University
Regulatory Affairs Graduate Certificate -
Humber College