Laboratoires Majorelle
- Pharmacien Affaires Réglementaires et Pharmaceutiques
2014 - maintenant
Mylan
- Central regulatory affairs (EMA)
SAINT PRIEST Cedex2014 - 2014
Chugai Pharma France
- Pharmacist, RA & QA
2012 - 2013- Registration of a biotechnology product in France, Belgium et Luxembourg : MA variation, FUM, PSUR
- Regulatory and competitive monitoring
- Writing of internal procédures
- Creation of internal formation tools
- Regulatory compliance : following of batches and technical claims
Marly-le-Roi 2012 - 2012- Country specific requirements coordination: coordination of the preparation of documents, samples, packaging components required for the registration, the submission of variations, Q&A at the international
- Process Improvement: harmonisation of ways of working, creation of procedures
CUSM McGill
- Intern University Health Care
2011 - 2011- Prospective study of thromboprophylaxis at the MUHC.
- Patient education
Chugai Pharma France
- Internship, Regulatory Affairs & Quality Insurance
2011 - 2011- RA: Regulatory compliance monitoring of promotional and environmental materials, creating a DMOS guide, regulatory and competitive monitoring, participation in the preparation of the certification audit of the hospital presentation of a drug, validating of DMOS record.
- QA: Following of lots and technical claims, creating Quality documents (Quality Manual, procedure of notice update).
- Belgium-Luxembourg: Writing procedures describing the business (management of samples, validation of promotional materials, and validation of donations).
MUHC Nantes
- Intern in Pharmacy, Nephrology-Immunology Dpt
MUHC Nantes
- Intern in Pharmacy, Laboratory management unit
2010 - 2010- Internal audit (ISO15189).
- Pre-analytical process for laboratory analysis.
In Cell Art
- Intern, Regulatory Affairs and Quality Assurance
2010 - 2010- Determination of the non-clinical studies required before first clinical use of a gene therapy product
- Creation of a quality system (ISO: 9001/2008)
