Associate Director, Regulatory Affairs and Scientific Writing
Séverine has an engineering diploma in Pharmacology from the Faculty of Sciences Nice Sophia-Antipolis (1999) and holds an MSc in International Drug Development and Registration from the Faculty of Pharmacy Paris Sud (2003).
Séverine has a broad experience in Regulatory Affairs and Scientific Writing in development, registration and lifecycle management activities, experience gained through numerous positions in the pharmaceutical industry and consultancy companies over the past 20 years.
She joined BlueReg in June 2019 as Associate Director, Regulatory Affairs and Scientific Writing.
Since 1999, Séverine has been developing her knowledge in global development and registration. After a decade working at Allergan within Clinical Quality and European Regulatory Affairs, Séverine joined Novartis in 2009 as Senior Regulatory Brand Manager where she was responsible for the EU centralised registration of two products in Cardiology.
She was then promoted to Global Program Regulatory Director in 2012, leading regional, local and expert regulatory colleagues, as well as a license partner. She defined the FDA and EU Health Authorities consultation strategy, providing regulatory input to the non-clinical and clinical Phase 2b development program in Endocrinology. She also led the worldwide registration strategies for a biological product in Dermatology and Respiratory areas, including a new registration in China and brand optimization projects globally.
In 2014, Séverine joined Scinopsis, a consultancy company in Medical Writing, developing her writing skills and rapidly became Senior Medical Writer within the company. She was in charge of writing key clinical and regulatory documents for company-strategic clients, for various products, regions and therapeutic areas, largely contributing to the overall company growth. She also coordinated writing teams on several key documents while mentoring more junior writers.
Through her professional experience, Séverine has developed her project management skills and teamwork spirit, and gained an extensive expertise in Regulatory Affairs and Medical Writing.