Marly-le-Roi
I am doctor in Pharmacy completed with a Residency in Pharmacy.
15 years of experience in Life science industry including 10 years of experience in Global Regulatory Affairs in various entities (small biotechs, GSK Biologicals and regulatory agency).
I have good knowledge of US and European in regulatory frameworks, especially in Biological products (vaccines, blood derived products and human tissues).
Currently I am working at GSK Biologicals where I have responsibilities in the global Clinical Regulatory Affairs Excellence group. I previously worked as Regulatory affairs Manager (at Santen SAS formely Novagali Pharma) where I covered clinical development and marketing authorisation activities (Centralised/Orphan) for both EU & US regions. I have also CE marked medical device.
I have successfully worked on clinical regulatory global development projects from phase 1 up to phase 3 and had interactions with a number of Health authorities including European Medicine Agency (EMA), ANSM (formerly Afssaps (French agency)), US FDA, Medicines and Healthcare products Regulatory Agency in United Kingdom (MHRA), Paul Erhlich Institute in Germany (PEI).
Specialties:
- Global regulatory affairs expertise and strategy in vaccines (Europe, Canada, US) and in ophtalmology (EU and US)
- Expertise in biological product (tissues, PMF, blood transfusion)
- Orphan drug designations
- CE Medical device marking
- Skills in Quality (ISO 9001, ISO 13485) and project management
- Knowledge in medical marketing
- Knowledge of the hospital environment and biological labs
Interpersonal skills:
- adaptive and flexible
- strong professional performer
- high level of energy/enthusiastic
- reliable and accurate
- team player and mentor
- high integrity and transparency level
- rapid and deep thinker/global thinker
- ability to learn fast in new aeras
Mes compétences :
Pharmacie
Industrie pharmaceutique
Gestion de projet
Santé
