Regulatory Affairs Associate
Resume:
Eman Bekhet
Milton, Ontario
E-mail:****.******@*****.***
CAREER OBJECTIVE: seeking to enter the pharmaceutical industry as a Regulatory Affairs Associate where I can apply my recent training in Pharmaceutical Regulatory Affairs at TIPT and my knowledge, experience and education to reach the company goals.
SUMMARY OF QUALIFICATION:
Pharmacy graduate with over 15 years of experience in the pharmaceutical industry
Recent graduate in pharmaceutical Regulatory affairs
Sound knowledge of the Food & Drugs Act and its associated regulations
Experience with different types of submission to Health Canada
Sharp, quick learner; excellent organizational skills, adaptable, willing to get involved.
Computer literate in Adobe, MS Word, Excel, Access and PowerPoint.
Bilingual in English, Arabic and good in French
Member of Canadian Association of Professionals in Regulatory Affairs (CAPRA)
REGULATORY PHARMACEUTICAL EXPERIENCE:
Regulatory affairs Co-op March 2019- June 2019
Toronto Institute of Pharmaceutical Technology, Toronto, Canada
Prepared eCTD Submission to Health Canada
Filled FRM-0033 for Drug Establishment Licensing
Prepared HC/SC3011 for CTA
Worked on filling NNHPD submission product licence Application Form for Cannabis Sativa (spray dosage form) and its Finished Product Specification form.
ACTS, REGULATIONS AND GUIDELINES
Knowledgeable with the Canadian Food and Drugs Regulations and guidelines
Compliance to all Regulatory requirement to support optimal Health Canada approvals and licensing
Assisted in implementing regulatory strategies and tactics to ensure that submission and documents are aligned with HPFB and ICH guidelines
ESTABLISHMENT LICENCE & SITE LICENCE REQUIREMENTS
Support compliance with Good Manufacturing Practices
Facilitated the preparation of Form FRM-003 for Establishment Licence to Health Canada
Worked on preparing and completing Site Licence Application Form for Site Licence
PRODUCT LICENCE REQUIREMENTS
Support filling and submission of Form HC/SC3011 for CTA and submission of NC
Preparation of Health Canada submission such as IND, NDS / NDA, ANDS / ANDA, CTA, DMF’s, NHP, compile the pre-approval and the post-approval submissions that meet the target dates.
Helped with preparation for Health Canada Meetings by preparing a letter to Health Canada and pre-meeting packages.
Preparation of Health Canada and FDA submission for eCTD utilizing Lorenz Doc-Bridge, Lorenz validation and Adobe Acrobat Pro II, all according to the applicable regulatory requirements.
Responsible for developing, compiling, filing documentation and support publishing
EDUCATION:
Post Graduate Diploma in Regulatory Affairs 2019
Toronto Institute of Pharmaceutical Technology (TIPT)
Toronto, ON
B.Sc. Of Pharmaceutical Science, Faculty of Pharmacy 1994
Cairo University, Egypt
WORK EXPERIENCE:
Pharmacy Assistant 2018-2019
Shoppers Drug Mart, ON, Canada
Confirmation of the accuracy of prescription information prior to filling
Data entry of patient care information into Health Watch
Accurate dispensing prescription medications
General OTC enquires from patients and referral to pharmacist
Pharmacy Manager
EMAN SOKKAR Pharmacies, Cairo, Egypt 1998-2017
Managed the pharmacy by processing broad-based and pharmacy-specific knowledge which allows for carrying any act involving professional and technical supervision, preparing and dispensing prescription and medications by compound packaging
Provide information on new medications to subordinates, interns, nurses or physicians
Provided, advised and helped patients with proper drug information, usage, and side effect, improving my advocacy skills and ability to understand people more and deal with their situation
Build consultation services to clients on different kinds of medication, reporting any adverse effect
Recruited, trained, and guided pharmacist and pharmacy technicians, to improve overall performance and working with various companies and medical representatives
Issuing contracts with hospitals and companies
Responsible for producing, recording, and arranging the pharmacy’s document
Pharmacist
Ain Shams University Hospital, Cairo, Egypt 1996-1997
Worked as a pharmacist in the inner surgical pharmacy to the department in the hospital for dispensing prescription medicines, working together with the medical and nursing team to ensure patients receive the best treatment and advising on the selection, dose, type of administration and documenting in addition to reviewing all those scenarios.
Production and Quality Control
El Nile Company for pharmaceuticals and chemical Industries, Cairo, Egypt 1994-1996
Reviewing production schedule and applying production control
Gathering information and generate knowledge using theoretical and experimental means
Testing new drugs, samples and other pharmaceutical products from all phases of manufacturing to meet the standards required.
References available upon request
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