-
XPE Pharma & Science
- Office personal
2014 - maintenant
-
GlaxoSmithKline Biological
- Regulatory and QA compliance personal
Marly-le-Roi
2012 - 2014
Regulatory Affairs Compliance Personal
* Checking of accuracy of data registered in regulatory documents (compared to operational documents: SOP, PV, BR) ;
* Analysis consolidation of data with experts in field ;
* Meeting of project deadlines ;
* Improvement suggestions of the process ;
* Working with different departments (RA, QA, Mfturing, QC) ;
* Risk assessment meetings planning and follow-up ;
-
Stallergenes
- Regulatory Affairs Associate International Regulatory Affairs - Allergenic
ANTONY
2011 - 2011
Stallergenes, Immunotherapy (Germany, Australia, New Zealand, Turkey, Portugal and South Africa)
* Registrations - Variations - Life cycle management ;
* Responses to Authorities questions ;
* Labelling control (Label, mock-ups, PI)
* Responses to subsidiaries' questions
* Change Control
* Submission package preparation
* CTD Module 3 ;
-
Pharmacie Principale
- Assistant pharmacist
2010 - 2011
-
Novartis Vaccines and Diagnostics, Bale, Switzerland
- Regulatory Affairs Associate
2010 - 2010
Registrations - Variations - Life cycle management
FUMs - SO
Responses to EMA questions
Submissions of CTA Amendments
Labelling control (Label, mock-ups, PI)
Tracking of European regulation
Responses to subsidiaries’ questions
-
Pharmacie Principale
- Assistant pharmacist
2009 - 2010
-
Baxter SAS France
- Regulatory Affairs Associate, Renal Division Europe
2009 - 2009
Preparation, Submissions and follow-up of Variation and Renewal files (Europe and International)
Type II Variations in MRP, National Licence
CCDS, Type II Variations
Type I Variations in MRP, National License
Change control
Participate as member of project teams
Responses to European and International subsidiaries
Database consolidation – CTD Module 3
-
Baxter SAS
- Regulatory Affairs Associate
2008 - 2009
Bioscience Division and Vaccines, Regulatory Affairs France
(haemophilia, Antibody therapy, Bio surgery, Vaccines)
* Submissions and follow-up of variation and renewal files ;
* Type II Variations, National Licence
* Type I Variations, National License
* Renewals ;
* Submissions of Clinical Trial Amendments( SMA) in France ;
* Labelling control: Work with Vienna Labelling Center ;
* Advertisement control: Work with Marketing Department ;
* Work with AFSSPS and RA partners ;
-
BAXTER SAS France
- Regulatory Affairs Associate
2008 - 2009
Bioscience Division and Vaccines, Regulatory Affairs France
(haemophilia, Antibody therapy, Bio surgery, Vaccines)
Submissions and follow-up of variation and renewal files
Type II Variations, National Licence
Type I Variations, National License
Renewals
Submissions of Clinical Trial Amendments( SMA) in France
Labelling control: Work with Vienna Labelling Center
Advertisement control: Work with Marketing Department
-
Grunenthal France
- Regulatory Affairs Trainee
2008 - 2008
Involved in preparation or checking of documentation
for submission of new products, for MAs variations and renewal files
Work with RA partners and HAs
Follow up of local regulations
Advertisement check-in
Provide documentation compliance and traceability
Quality audits (contractors, manufacturers)
Follow up of Charter of Reps
-
Carrefour Lievin, France
- Manager Parapharmacy
2003 - 2007
Head of the personal hygiene products department, Parapharmacy
-
Pharmacie Jeanne
- Assistant pharmacist Manager
2002 - 2003
-
Pierre FABRE
- Medical representative
Castres
2000 - 2002
* Responsible for registration in Cameroon: Contact Person for National authorities ;
-
Wyeth-Lederle Laboratory
- Medical representative
1998 - 2000
* Responsible for registration in Cameroon (Contact person with National authorities) for the following Laboratories: Servier, Wyeth, Glaxo Welcome, Lederlé, Theramex (TRIDEM PHARMA) ;
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Ranbaxy Laboratory
- Medical representative
1997 - 1998
* Contact with doctors, nurses and opinion leaders ;
