Senior Regulatory and Pharmaceutical Affairs Advisor
Doctor of Pharmacy
DU Analytical development and control of natural and synthetic drugs (PARIS V)
Fabien is a Doctor of Pharmacy with a specialization in the development and control of natural and synthetic drugs (Paris).
He began his career in a major French pharmaceutical laboratory, Sanofi-Aventis, first in Regulatory Affairs within the France subsidiary and then for short missions as an outsourcing service provider within the Industrial and External Pharmaceutical Operations located on the Croix de Berny site, in Anthony (92).
He then turned to the field of allergology and specific immunotherapy, then undergoing major changes in the mid-2000s, to work at ALK France, a specialist laboratory and world leader in this field.
As a Regulatory Affairs Pharmacist, Fabien actively participated within the subsidiary not only in obtaining and maintaining the first authorizations for this type of product in France but also in the development of the subsidiary and its product portfolio, in close collaboration with the Danish headquarter.
Therefore, with a view to extend his scientific and technical knowledge, Fabien turned to Regulatory and Pharmaceutical Affairs Consulting Company (I.D.D.), then structured around two main areas of activity: development and consulting.
Thus, during the 12 years spent in a consulting company, Fabien has expanded his field of expertise on the aspects of pre-MA (development of a topical product under hybrid status, scientific advices) and post-MA (quality and technical-regulatory compliance of regulatory dossiers, change control management, drafting of variations, renewal, product information management, monitoring of European procedures, strategy of responses to authorities, evaluation of PQR…) in contact with a large number of players in the pharmaceutical industry (national and international companies, medicine authorities and external partners including a network of experts, CROs, contractors, API manufacturers and other subcontractors).
With his experience, Fabien can work both in project mode to plan and manage cross-functional activities and in delivery mode, dedicated to a client.
Over the past year, he has also contributed to the development of activities related to ‘Exploitant’ status (pharmacovigilance, advertising and medical information).