Frederic has several responsibilities within Voisin Consulting Life Sciences (VCLS). As a Head of Regulatory Science, he provides leadership and support to the European team of regulatory scientists, and as Senior Director, he is responsible for the management of projects involving the design and implementation of global regulatory strategy for the development, evaluation, and marketing of small molecules and biologics.
In addition, as Qualified Person, Frederic is responsible for developing QP/QA-related services for European, US and Swiss clients who wish to outsource the building and maintenance of local Quality Management System activities in Europe. As a result, he has developed an in-depth knowledge of EU Good Manufacturing Practices and Good Distribution Practices and is responsible for drug product batch release onto the Swiss market.
Frederic brings to the role more than 16 years’ experience in the pharmaceutical industry, together with 10 years’ experience as a Consultant, which has given him extensive experience of coordinating all aspects of European submissions; from pre-filing dialogue with the Authorities to the granting and maintenance of Marketing Authorizations. During this time, Frederic has gained an in-depth knowledge of EU regulatory requirements (including Pediatric Investigation Plans and Orphan Drug Designation applications), as well as Swiss registration procedures, and he has prepared and driven numerous meetings with Health Authorities/bodies, including for National and European Scientific Advice.
Prior to joining VCLS, Frederic worked for Pierre Fabre Medicament and Ipsen Pharma where, as Director Europe Coordination, he was responsible for providing European input to global regulatory strategies and implementation plans, for leading European operational regulatory activities, and for supervising tactical regulatory aspects for non-EU countries.
Frederic started his career working for Orphan Europe (an SME, but now part of Recordati Group), where he successfully led requests for Orphan Drug Designations and Marketing Authorization Applications.
Frederic earned his Pharm.D degree from the University of Pharmacy of Tours, France. He also holds an M.Sc. in Health/Drug Law, Marketing and Management of Pharmaceutical Industries from the University of Bordeaux, France.