Bastien Magnaldi
About Bastien Magnaldi
Bastien Magnaldi is a Senior Product Manager and Area Leader in Regulatory Affairs with extensive experience in the pharmaceutical industry, particularly in the registration and lifecycle management of injectable sterile products. He has worked for several notable organizations, including Sanofi Pasteur and Mylan, and holds a Doctor of Pharmacy degree from Université Claude Bernard Lyon 1.
Work at Laboratoire Aguettant
Bastien Magnaldi currently holds the position of Regulatory Affairs | Senior Product Manager & Area Leader at Laboratoire Aguettant. He has been with the company since 2021, contributing to the regulatory affairs team in Lyon, Auvergne-Rhône-Alpes, France. His role involves overseeing regulatory compliance and managing product lifecycles, particularly focusing on injectable sterile products.
Education and Expertise
Bastien Magnaldi earned his Doctor of Pharmacy (PharmD) degree from Université Claude Bernard Lyon 1, where he studied Industrial Pharmacy from 2014 to 2016. Prior to that, he attended Université Grenoble Alpes, completing his Pharmacy studies up to the 5th year from 2008 to 2014. He possesses expertise in technical writing for Chemistry, Manufacturing, and Controls (CMC) worldwide submissions, specializing in the registration and lifecycle management of injectable sterile products.
Background in Regulatory Affairs
Bastien Magnaldi has extensive experience in regulatory affairs, having worked in various capacities across multiple organizations. He served as a Regulatory Affairs - CMC Project Manager at Sanofi Pasteur from 2016 to 2021, where he managed regulatory submissions and compliance. His earlier roles include positions at Mylan and Juvisé Pharmaceuticals, where he focused on EU registration and lifecycle management. He also completed an internship at CHU Grenoble Alpes in pharmacy.
Professional Experience Timeline
Bastien Magnaldi's professional journey includes significant roles in regulatory affairs. He began with an internship at Mapi Group in 2015, followed by a position at Juvisé Pharmaceuticals for six months. He then worked at Laboratoire Aguettant in 2015-2016 before moving to Mylan for 11 months. He returned to Sanofi Pasteur for two years before joining Laboratoire Aguettant in 2021, where he continues to advance in his career.
Research and Publications
Bastien Magnaldi authored a thesis titled 'Regulatory Environment of Biosimilars,' contributing to the academic discourse on biosimilars and their regulatory challenges. This work reflects his deep understanding of the regulatory landscape and his commitment to advancing knowledge in the field of pharmacy and regulatory affairs.