Mohamed CHEBIRA

En résumé

Entreprises

• 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
  requirements.
  11. Manage the work activities of Quality Assurance
  Department.
  12. Manage inspection of incoming new materials and conduct
  material evaluation to determine acceptability based on
  purchase acceptance standard set by the company.
  department.
  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
  department.

• Hikma Pharmaceuticals - Medical Representative

  2003 - 2003 Presentation of antibiotic brands to health care professionals

Formations

• University Of Jordan (Amman)

  Amman 1998 - 2003 Pharmacy
  
  Pharmacy Departement

Réseau

• Abderrahmane AMALOU

• Atlan PATRICK

• Dounia EL BEJJAJ

• Karim AHNICHE

• Mélanie BLANCHARD

• Narimane IMACHE

• Samir DEKAR

• Tahar DAOUDI