Mes compétences :
API
CEP
Création
eCTD
GMP
HPLC
optimization
Pharmaceuticals
Process
Process improvement
Process Optimization
Regulatory Affairs
Requirements
Entreprises
Sanofi Pasteur
- Regulatory Affairs Specialist
Lyon2012 - 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
Paris2011 - 2011Submission 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
Lyon2010 - 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
Lyon2010 - 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.
