Sébastien Genève heads the European Practice of our Regulatory team; providing consulting services to industry and counsel on regulated healthcare products. He has over 20 years of experience in pharmaceutical product development globally, and Regulatory Affairs. Previously, he was Vice-President of Regulatory Affairs at Bayer Consumer Care and Acino. Prior to joining Bayer, he was the Director of Regulatory Affairs EMEA for the pharmaceutical division of Bausch & Lomb. He has also held various regulatory positions with Roche Consumer Health in Europe as well as Galderma in Europe and the USA.
Sébastien Genève has extensive EU and global experience in developing regulatory strategies, product development plans, regulatory submissions, and product defense/ communication strategies for drugs, cosmetics, and medical devices. He has strong skills in analyzing the scientific and regulatory aspects of potential new products.
Sebastien Genève has been responsible for Marketing Authorizations Applications (MAA) and Clinical Trial Applications (CTA) in Europe, Investigational New Drug applications (INDs), and other regulatory filings as well as responsible for the Medical and Pharmacovigilance functions in the last years. In addition, he has extensive experience in EU Health Authority (EMA and EU Member States) meeting preparation and management.