En résumé


As my résumé demonstrates, my current experience as a Regulatory Affairs specialist supporting the CMR organization, combined with my previous experiences as Production Manager and Qualiy Manager as well as a Project Coordinator, provided me with an excellent insight and experience in managing mission-critical projects and contributing to business development initiatives with the knowledge to balance the requirements for quality, functionality, economy and timeliness in different fields of expertise. I’m highly committed, resilient and tenacious with excellent communication and interpersonal skills.

Mes compétences :
Quality Assurance
Regulatory affairs
Pharmaceutical industry
Microsoft Office
Gestion de la qualité


  • Abbott Laboratories - Senior Regulatory Affairs Specialist MEAP

    Rungis 2016 - maintenant
  • Abbott Products Algeria - Regulatory Affairs Manager / Directeur Technique

    2015 - maintenant •Define the regulatory strategy for the current and upcoming registrations.
    •Cooperate with the supply chain and marketing departments for proper Business Case preparation.
    •Preparing submissions of registration dossiers (Variations, renewals and new drug applications).
    •Preparing/validating/approving packaging materiel according to the local standards/regulation.
    •Validate and submit promotional materials according to local requirements
    •Follow up the local partnership with the third party manufacturer TPM (LDM, Biopharm and AT Pharma).
  • Novo Nordisk - Regulatory Affairs Specialist

    La Défense Cedex 2013 - 2015
    • Manage the life cycle of the NovoNordisk A/S Algeria product Portfolio.
    • Preparing submissions of registration dossiers (Variations, renewals and New drug applications)
    • Following up registration process until marketing authorizations approval;
    • Preparing/validating/approving packaging materiel according to the local standards/regulation and NN procedures.
    • Validate and submit promotional materials according to local requirements
    • Manage and maintain the regulatory database system (RIMs)
    • Follow up the exportation project from a regulatory vintage point.

  • Sanofi-Aventis - Quality Manager

    Paris 2010 - 2012 •Promoting quality achievement and performance improvement throughout the organization,
    •Formulate and manage the development and implementation of goals, objectives, policies, procedures and systems pertaining to the QA/QC,
    •Develop, implement, communicate and maintain a quality plan to bring the company’s Quality Systems and Policies into compliance with quality system requirements,
    •Working with purchasing staff to establish quality requirements from external suppliers,
    •Writing technical and management systems reports,
    •Bringing together staff of of different disciplines and driving the group to plan, formulate and agree comprehensive quality procedures,
    •Persuading reluctant staff to change their way of working to incorporate quality methods,
    •Manage and maintain the Company’s quality inspection and product release programs for incoming and in – process materials and components, processes and finished products,
    •Assessing the product specifications of the company and its suppliers, and comparing with customer requirements,
    •Considering the application of the environmental and health and safety standards,
    •Setting up and maintaining controls and documentation procedures,
    •Liaising with customer’s auditors and ensuring the execution of corrective action and compliance with customer’s specifications.
  • Frater Laboratories - Production Manager

    2010 - 2010
  • Prodiphal Production - Regulatory Affairs Manager

    2009 - 2009 1. Registration dossiers completion
    2. Registration dossiers submission and follow up
    3. Registration dossiers reimbursment submission and
    follow up
    4. Batches systematic control completion
    5. Batches systematic control submission at the LNCPP
    6. Artwork translation and validation at the LNCPP
    Partners : Novartis Pharma, Novartis Consumer Health,
    Schering Plough, Janssen Cilag, Iladj Pharmaceuticals
  • Hikma Pharmaceuticals - Regulatory Affairs Pharmacist

    2008 - 2009 1. Order the registration requirements of the dossiers relative to
    pharmaceutical drugs planned to be registered as local
    production and importation.
    2. Submit and follow up the registration dossiers with local
    Health Authorities.
    3. Implement a filing system of registration track and follow up.
  • Hikma Pharmaceuticals - Project Coordinator/Quality Assurance Manager

    2004 - 2008 1. Participate in the implementation of the investment of Hikma
    Project in Algeria (Plant of manufacturing pharmaceutical
    preparations) .
    2. Order Raw and packaging Materials and inspect the quantities
    received. Also order laboratory material, equipment and
    production machines and inspect the received merchandize.
    3. Handle customs clearance of the raw and packaging materials,
    production machines and laboratory equipment.
    4. Prepare annual manpower plan and make sure all vacant
    positions are filled in coordination with Human Resources.
    5. Prepare production budget and maintain/improve budget
    limitations to meet plant’s annual objectives and standards
    according to sales projections.
    6. Establish production scheduling and recording system that
    will ensure accurate recording of production figures and
    stoppage analysis to make timely and precise reports for
    company management and future planning.
    7. Implement the Standard Operating Procedures,
    Manufacturing Orders and Packaging Standards to Hikma
    Pharma Plant.
    8.Supervise the Validation batches processes along with the
    Quality Control and Regulatory Departments.
    9. Responsible in maintaining/developing the product quality,
    batch formulation, quality & process audit.
    10. Manage and monitor the quality of all finished products to
    maintain the company’s high standards and meet the market
    11. Manage the work activities of Quality Assurance
    12. Manage inspection of incoming new materials and conduct
    material evaluation to determine acceptability based on
    purchase acceptance standard set by the company.
    13. Establish safe working procedures in the area of
    responsibilities to keep the number of accidentto the minimum or zero.
    14. Ensure proper training of Q.A. technicians to upgrade their
    knowledge required to maintain high quality standard.
    15. Implement statistical process control in quality assurance
  • Hikma Pharmaceuticals - Medical Representative

    2003 - 2003 Presentation of antibiotic brands to health care professionals


  • University Of Jordan (Amman)

    Amman 1998 - 2003 Pharmacy

    Pharmacy Departement


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