As Director, CMC, Nicole Cohen is responsible for the management of projects involving regulatory and Chemistry Manufacturing and Control (CMC). She participates in the definition and implementation of CMC regulatory strategies for development and registration of innovative drugs, covering small molecules (including radiopharmaceuticals) as well as biologics and their association to medical devices in combination products. She also has experience in generic products development and their regulatory dossiers and has been involved with the development of innovative immunotherapy products for the treatment of food allergies.
Nicole combines her regulatory CMC experience with specific expertise in analytical development, formulation, stability studies set up, and packaging materials agreement including compatibility studies.
She has significant experience in regulatory dossiers strategy and positioning for regulatory applications (IND, IMPD, MAA, BLA/NDA, as well as post approval Life Cycle Management). She also managed numerous Agency meetings (FDA, EMA, and EU national Agencies) in relation with early and late development of various medicinal products and provided support to the preparation of associated briefing documents and face to face meetings.
Nicole brings more than 25 years of experience in the pharmaceutical industry during which time she has acquired in depth knowledge and understanding of EU, US regulations and GMPs. She also was a trainer for the pharmaceutical industry teaching on regulatory CMC requirements, implemention of relevant guidelines during development studies and authoring of MAA dossiers.
Prior to joining VCLS, Nicole was Head of Analytical/Pharmaceutical Development and Regulatory CMC in international companies working within multidisciplinary international project teams including 2 years at DBV-technologies and 5 years at Ipsen Pharma. Nicole was also Pharmaceutical and Non Clinical Manager at Orphan Europe for 6 years.
Nicole obtained a PhD in Science, Biological and Physico-Chemistry from the University of Paris in specialization in Biopolymers for the controlled release of encapsulated drugs.
She is also graduated as Bioindustry engineer from University of Paris.
Nicole is based in the Boulogne office in France