Nathalie HAUGUEL
À propos du candidat
Regulatory Compliance Director
Doctor in Pharmacy (Pharm D)
Localisation
Formations
- Master « Health Legislation » – Pr. Fallet. University Chatenay-Malabry/Sceaux – Paris 11
- Doctorate in Pharmacy - University René Descartes – Paris 5 Master « Biodynamie-Biopharmacie » - Pr. Schermmann
Expériences professionnelles
– Scientific and Regulatory Compliance Director Direct management of 5 people (8 people team) Global and French subsidiary regulatory and quality activities New activity added: Setting up and leading of the global quality system
– Scientific and Regulatory Compliance Manager Management of a 4 people team Global and French subsidiary regulatory and quality activities New activities added: Setting up and leading of the French quality system (deviation, CAPA, change control, audit plan, KPI …) Management of medical devices and food supplements
- Scientific and Regulatory Manager Management of 1 person Global and French subsidiary regulatory activities of medicinal products Management of regulatory dossiers, CTA, “anti-gift” and sunshine act regulations, “charte de la visite médicale”, reimbursement and price dossiers
- Regulatory Affairs Manager Management of a 3 people team Global regulatory affairs activities Leader of the global registration strategy worldwide for one range of injectable products
- Regulatory Affairs Officer Global regulatory affairs activities Management of global registration strategy worldwide of one injectable product (national, MRP/DCP)
– Regulatory Affairs Officer French subsidiary regulatory affairs activities Promotional materials validation, BAT validation, CTA, MAA (national, MRP and centralised procedures)
- Clinical Research Associate Management of clinical trials in hepatology and oncology
