Quality & Regulatory Affairs Consultant
Florence is university graduate of Lyon both in Life Sciences (2002) and Quality Management (2003).
Florence has more than 10 years of experience in the pharmaceutical industry, especially in the field of Quality Management System and Regulatory Affairs (France).
Florence started her professional career in 2003 where she held the position of Quality Assurance Assistant at GECITECH. She was in charge of setting up ISO 9001 norm for which the company obtained its certification in 2005. In 2006, she was recruited to SOLVAY PHARMACEUTICALS as FDA Project Assistant where she took part of a quality system’s development in accordance with cGMP and succeeding in FDA’s approval in 2007.
Between 2007 and 2011, she worked for SANOFI PASTEUR and MYLAN as Regulatory Affairs Associate. She was responsible for preparing regulatory submission files such as renewals, variations and responses to questions, under national (French) and European procedures (Decentralised Procedure, Mutual Recognition Procedure and Centralised Procedure).
In 2012, she was employed by GENZYME as Packaging and Regulatory Affairs Technician. She was in charge of developing artworks for packaging’s items according to regulatory approved texts in European countries and more widely on an international stage (USA, Brazil, Morocco, etc.).
After 10 years’ experience in pharmaceutical companies, Florence oriented her career in the consulting and joined BLUE-REG PHARMA CONSULT, in September 2013.
She has developed the quality system of the company which she now manages as quality manager. She participates in quality client projects through the audit of French “exploitant” activities, the writing of procedures and the advice on quality management systems. She also assists clients in consulting, training or project management in the field of relationships between healthcare professionals and pharmaceutical companies.