Julien is team leader and leads projects from early development to MAA filing and launch of healthcare products. He advices on regulatory strategy, oversees preparation and submission of MAA and interacts with Authorities globally for clients’ products.
Julien has extensive experience in pre-submission activities such as CTA, ODD, PIP, scientific advice meetings for medicinal product across broad range of therapeutic areas. He also provides strategic and operational support for the development and life-cycle management of medical devices, IVDs and combination products, including product classification, preparation of Clinical Evaluation Reports and Technical Documentation, and interactions with Notified Bodies.
He also advices on regulatory intelligence projects, preparing high quality documents and customized newsletters for clients.
Julien holds a PhD in Neurobiology from the Center of Molecular Life Sciences of the University of Basel, Switzerland, and obtained an MSc in Neuroscience from the University of Strasbourg, France.
SFL Regulatory Affairs & Scientific Communication Ltd.