Senior Director, Regulatory Operations
- Europe, Middle East, Africa, Russia/CIS, Australia/New Zealand registrations & life cycle management
- Worldwide geographical roll out & launch activities
- Safety & CMC compliance projects
- Development (SA, PIP, ODD, CTA, due diligence)
- Project & Team Management
Nadia is an engineer in Pharmacology (Master degree, Faculty of Sciences of UNSA, France 1999). She completed her Pharmaceutical education by continuous training at the Faculty of Pharmacy of Paris XI, France (2000) with a Master Degree in Development & International Registration of Medicinal Product.
Nadia is a senior regulatory affairs professional specialised in development, registration & maintenance of medicinal products. She is experienced in global project & team management with broad understanding of international regulations, processes and issues in drug development and proven track record of successful registrations worldwide.
She has extensive regulatory affairs experience in EMEA and export countries gained through several positions in pharmaceutical industry and consultancy companies over the past 20 years.
Nadia is also a trainer for CEFIRA, a training organisation for research & pharmaceutical industry, since 2005.
Prior to joining BlueReg Group, Nadia was at Galderma R&D for 6 years, where her most recent role was Head of the EMEA Regulatory Affairs Team on Rx drugs. In this role, she led a group of regulatory professionals, worked within global project team and had responsibility for the registrations (centralised, decentralised, MRP and national procedures). She also was involved in brand optimisation strategies, was coordinating the global promotional material validation & was responsible for the lifecycle management of prescription portfolio, covering around 100 countries around the world.
Nadia has also gained experience in consultancy as Associate Director in Regulatory Affairs & Business Development and as European Regulatory Project Manager in other consultancy companies. During these 6 past years of consultancy, she acquired a solid expertise in multiple therapeutically ranges of pharmaceutical products, also including OTC drugs.
Finally, Nadia also spent 8 years as Regulatory Affairs Senior Manager at Allergan R&D where she managed a cross-cultural regulatory team and was involved in the development (CTA Phase III and II, IMPD, IB, protocol review), registration (CP, DCP, MRP) and maintenance of the eye care portfolio.
At BlueReg Group, Nadia is managing the Regulatory Operations team by providing services in worldwide registrations, maintenance and publishing activities.