Chaïma MRIZAK

Experience

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  Delivery Pharmacy

  Jul 2010 - Aug 2010

  Pharmacy Internship (initiation)

  Initiation to the job of officinal pharmacist.Advising patients (locals and tourists) in local and foreign languages especially for cosmetic products.

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  Pediatric Service - CHU Farhat Hached

  Aug 2012 - Aug 2012

  Nursing Internship

  Traineeship within the hospital pharmacy department and the pediatric serviceMissions:*Initiation to the work in a hospital pharmacy department*Drug use in the pediatrics service*Practice of aseptic*Injection and infusion*Samples for analysis*Vital signs monitoring

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  Endocrinology Service - CHU Farhat Hached Sousse

  Sept 2013 - Feb 2014

  Intern Pharmacy (Clinical Pharmacy)

  *Clinical Pharmacy:- Introduction of concept of pharmaceutical record in service: Redaction of a record copy to be filled according to international recommendations (past and ongoing treatment, prospective adverse effects, analyze pharmaceutically the collected informations)- Consulting with the patient’s physicians and other health care providers in selecting the medication therapy that best meets the patient’s needs and contributes effectively to the overall therapy goals.- Following the patient’s progress to determine the effects of the patient’s medications on his or her health.- Educating patients and advise them on how to best take their medications.- Pharmacovigilance: notifying side effects*Participation in the development of the "Therapeutic Booklet, Edition 2014 " : This book details the drug circuit at the hospital, the different types of orders and legislation on prescription. It is a tool of practical help with prescription and proper use of medications.* Redaction of a bibliographic study on "Glycemic Diabetic Self-Monitoring: Indications, methods and interests" which contains many advices to the health professionals and patients.*Comparative study between three glucometers available at the Endocrinology service. This study aims to examine whether there are significant differences between measurements made by different devices tested. Show less

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  Delivery Pharmacy

  Mar 2014 - May 2014

  Intern Pharmacist

  Financial managementHuman Resource ManagementValidation and dispensing medical prescriptions, Patient adviceMagistral and officinal preparationsInventory management: preparation and orders receipt, inventory

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  Laboratory of immunology-CHU Farhat Hached

  Jun 2014 - Aug 2014

  Intern Pharmacist (Biology)

  *Accomplishment of a research project in auto-immunity for obtaining the degree of Doctor of Pharmacy. The work was on type 1 diabetics versus a control group in which we screened for an associated auto-immune antibodies.Thanks to this work, I had the mention Very Honorable with the congratulations of the jury and a thesis price proposition.*Routine reactions: Screening for diffrent auto-immune diseases. Mastering ELISA and IF techniques*Intervention in clinical services and communication with doctors and medical stuff about difficult and urgent cases*Management of reagents Show less

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  Institut Pasteur de Lille

  Feb 2016 - Aug 2016

  Research Master 2 Intern

  Working on an innovative research project in the field of immune-oncology in collaboration with Oscar Lambret Hospital Center.This project thoroughly study a connection between breast cancer, chemotherapy and immune system.I participated in the start-up of the project, set the protocol point and generated the first results. This work required the mastery of several techniques such as cell culture, ELISA, manipulating chemotherapeutic drugs, working in a clean room, under MSP (Microbiological safety post) and in hypoxia station, etc. Show less

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  Sanofi

  Apr 2017 - Sept 2017

  Global Regulatory Affairs Intern

   Update of marketing authorisations: preparation of renewal and variation dossiers for sending to affiliates  Follow-up of submissions and approvals of variations (administrative, CMC-related and labelling variations) to subsidiaries  Industrial implementation of changes impacting labelling  Validation of packaging items and translations of leaflets, package inserts, labelling and approval letters (English, French, Arabic)  Coordination of the renewal activity within the team & setting-up of a track system for renewal submissions to affiliates. Show less

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  AstraZeneca

  Jan 2018 - Jun 2019

  Regulatory Affairs Pharmacist (CGI contractor)

  • Managed regulatory activities across 12 French-speaking African countries for a portfolio of 40 products (oncology, cardiovascular, respiratory, endocrinology)• Coordinated with local representatives, global teams, affiliates, and external service providers to ensure compliance with regional and global regulations.• Implemented regional procedures and contributed to contract drafting with distributors.• Participated in defining regional regulatory strategies and supported global projects. Show less

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  CGI

  Jan 2018 - now

  Regulatory Affairs Consultant
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  Sanofi

  Mar 2020 - Mar 2023

  • Defined and executed global regulatory strategies for major markets (EU, LATAM, China, Japan, etc.) to align projects with regulatory constraints.• Coordinated cross-functional teams for regulatory activities related to API and packaging rationalization projects.• Monitored submission timelines and ensured compliance with regulatory frameworks * Defined the regulatory strategy for 46 African countries * Coordinated of the regulatory package through several departments (CMC, quality, labeling, packaging, supply chain and market access) * Coordinated labelling update activity within the team (worlwide)* Managed prioritization, challenging & tracking of submissions and approvals with local affiliates

  • Regulatory transversal lead (Project & Performance management team) (CGI contractor)

    May 2021 - Mar 2023

  • Regulatory affairs manager - Manufacturing site transfer (CGI contractor)

    Mar 2020 - Jun 2021