Director Regulatory Affairs, Drugs & Biologics
- Project management
- Global Development of Drug products including Biologics
- Marketing Authorization Applications (NDAs/MAAs)
- Agency meetings with numerous Health Authorities (FDA, EMA, PMDA, EU national)
- Clinical Development and Clinical Trials (INDs,CTAs)
- Pediatric Plans and ODD
- CMC (Variations, Module 3)
Pharm.D – Montpellier School of Pharmacy (1998) RAC European Reg Affairs – Lille School of Pharmacy (1999)- France
Caroline has a significant experience in Regulatory Affairs gained through more than 19 years of working within the pharmaceutical industry or consultancy company, and more than 15 years in Registration and Drug Development.
Prior to joining BlueReg Pharma Consulting, Caroline was at Galderma Nestlé Skin Health, where her most recent role was global Senior Regulatory Affairs Manager in charge of the development of a monoclonal antibody in Dermatology. She was also responsible of the global development of products in various dermatological conditions including rare diseases and oncology. She managed successful submissions and approvals of EU MAAs and NDA. Before joining Galderma, she worked for consultancy for 2 years for various regulatory activities in Europe.
She started her career in Allergan where she was initially in charge of the French territory and then moved to the European Regulatory team. She was in charge of the European registration of Ophthalmic products in Europe. She then joined the botulinum toxin division where she oversaw the maintenance of the Botox license in EU as well as various development projects on botulinum toxin.