Séverine Waterdrinker

Séverine Waterdrinker has diverse and extensive work experience in the field of regulatory affairs and medical writing. Séverine is currently employed as a Principal Medical Writer at Sobi. Prior to this, they worked as an Associate Director in Regulatory Affairs and Scientific Writing at BlueReg Group from 2019 to 2022.

Before joining BlueReg Group, Séverine worked at Scinopsis medical writing as a Senior Medical Writer. In this role, they wrote various documents for Europe, United States, and Asia, including Clinical Study Reports, Briefing documents for scientific advice, Paediatric Investigation Plans, and CTDs. Séverine also mentored junior staff and worked on projects related to chemicals, biologicals, gene therapies, and medical devices in various therapeutic areas.

Earlier in their career, Séverine held positions at Novartis as a Global Program Regulatory Director, Senior Global Program Regulatory Manager, and Senior EU Regional Brand Regulatory Manager. Séverine was responsible for regulatory activities in critical care, dermatology, respiratory, metabolism, cardiovascular, and other therapeutic areas.

Additionally, Séverine worked as a Clinical Trials Directive trainer at CEFIRA and held multiple roles at Allergan, including Senior Manager Regulatory Affairs and Regulatory Affairs Manager.

Their career started at Virbac, where they worked in Regulatory Affairs for Europe.

Overall, Séverine Waterdrinker's work experience demonstrates their expertise in regulatory affairs, medical writing, and diverse therapeutic areas.

Séverine Waterdrinker has a Magister of Pharmacology (Master) degree in Biochemistry and Molecular Biology from Université Côte d'Azur, which they completed between 1994 and 1999. Séverine also holds a DESS in International Drug Development and Registration (Master) from Paris-Sud University (Paris XI), completed in 2002-2003. Séverine is currently pursuing a Bachelor's degree in Psychology (clinical - developmental - cognitive - social) at Université Paris 8, with an expected completion date in 2023. In terms of additional certifications, Séverine has completed the online self-study program in Basics of Health Economics with CELforPharma in 2021, the course on Overview and Current Status of Immunotherapy and CAR-T Cell Therapies with CfPA - The Center for Professional Advancement in 2020, and the course on Clinical development and assessment for regulatory and reimbursement purposes in Europe (HTA) with Medicines Development and Training (MDT) services in 2019. Séverine also has experience as a research trainee at Université libre de Bruxelles in July-August 1997 and at Stony Brook University (State University of New York) in July-August 1998.