Jenny ALMENDRA
Senior CMC & Regulatory Affairs Advisor
PhD in Pharmacy
Master's degree in Drug Quality Control and Assurance
Holding a Doctorate in Pharmacy and a Master’s in Drug Quality Control and Assurance from Paris XI University, Jenny brings nearly 20 years of experience in the regulatory field concerning CMC activities of products.
She began her career at MediBridge, where she worked for 7 years on various missions ranging from strategic registration advice to technical-regulatory management, with a particular interest in drafting and updating sections of Module 3.
Subsequently, Jenny served as the CMC Regulatory Project Manager at Servier Laboratories for 3 years, managing a portfolio of both new and mature products. Her role involved overseeing Modules 3 for obtaining and maintaining marketing authorizations in Europe and internationally.
Over the past 8 years, Jenny has specialized in auditing and drafting MA dossiers (modules 1, 2.3, and 3) at AR2i, focusing on complex projects, including the exploitation of technical data for regulatory purposes (process or analytical validation reports, stability studies, risk analyses, etc.), for both new and existing authorizations and pharmaceutical variations.
She has also participated in monitoring and training missions on regulatory or pharmaceutical topics.
Jenny joined ATESSIA in March 2024 as a Senior Consultant in CMC Regulatory Affairs
