Rosa KHELIFA

En résumé

Entreprises

• Sanofi Pasteur - Regulatory Affairs Specialist

  Lyon 2012 - maintenant - Submission of a variation application for a new quality profile of a Working Seed Lot.
  - Submission of a variation application for a modification in the process manufacture to comply with the GMP requirements.
  

• Akka Technologies - Regulatory Affairs Specialist

  Paris 2011 - 2011 Submission and follow-up of CEP dossier (European Certificate of Compliance to Pharmacopoeia) and DMF (Drug Master File)
  
  Achievements
  - Drafting CEP and DMF dossiers
  - Submission of Dossiers to EDQM and FDA
  - Deviation’s follow-up due to a site production transfer
  - Preparation of customer documentation folders (open part) upon customer demand
  - Answer to Health Authories (EDQM) throught deficiency letters
  - Answer to customer requests (Europe, United States, Japan)
  - Management of Annual Report updates
  Results
  - Knowledge of European and US registration procedurs of Active Product Ingredient (API)
  - Skills development in drafting of registration's dossiers on CTD format
  

• Sanofi-Pasteur - Regulatory support at Reg CMC-Global Standards department

  Lyon 2010 - 2010 - Participation to the implementation and improvement of global regulatory processes
  - Reviewing and approval of Regulatory Affairs documents
  - Procedures drafting.

• Sanofi pasteur - Training course Global Regulatory Affairs at Reg CMC-Global Standards Department

  Lyon 2010 - 2010 - Participation to the implementation and improvement of global regulatory processes in close relationship with US/CA sub team.
  - Impact assessment of the new European variation regulation on Regulatory Affairs processes Tools.
  - Regulatory Change Assessment Guide: Update and improvement.
  - Elaboration of training kits relevant to Regulatory Affairs process (Annual Report, management of contact report with health authorities).
  - Procedurs drafting.
  - Participation to the Sanofi Pasteur Trainee Day.

• Mérinal Laboratories - Training course : Quality Control

  2009 - 2009 - Participation to the update of Quality Control SOPs for bulk and final lot control.
  - Daily operational quality control activities: physico-chemical testing (HPLC, spectrometry).

• Institut des Biomolécules Max Mousseron - Training course in Polymer Analysis

  2008 - 2009 - Project research : “Analyse of the polyelectrolyte’s behaviour in different media by capillary electrophoresis”
  - Bibliographic research, test performing.
  - Presentation of the data and report to the team.
  - Scientific results have been used in scientist publication.

Formations

• Faculty Of Pharmacy Of Montpellier

  Montpellier 2009 - 2010 Master 2 degree, Production Engineering and Project Management

• Faculty Of Pharmacy Of Montpellier

  Montpellier 2008 - 2009 Master 1 degree, Biology & Health

• Faculty Of Pharmacy Of Algiers (Algiers)

  Algiers 2003 - 2008 Pharmacist graduation - Theses title : “Epidemiologic study of nosocomilas deseases cosed by Pseudomonas aeruginosa”

Réseau

• Akka TECHNOLOGIES

• Anne-Sophie VECK MICHAUT

• Elisabeth LAGIER

• Florian TROUILLER

• Julien DUTHEIL

• Siem DJEMIL

• Stéphanie TINEL

• Thibault PATRIER

• Wafa Manel DJIAR