Caroline Robo (Fesquet) has extensive experience in the field of regulatory affairs. Caroline currently holds the position of Director of Regulatory Affairs at Amolyt Pharma, a role they have held since September 2020. Prior to this, Caroline worked as the Director of Regulatory Affairs, Drug & Biologics at Blue Reg Pharma Consulting from April 2018 to September 2020.
From 2011 to 2020, Caroline worked at Galderma as the Global Senior Regulatory Affairs Project Manager. In this role, they were responsible for regulatory strategy development for global projects, including biologics. Caroline also had experience with regulatory consultations, MAA/NDA submissions, clinical study submissions, orphan applications, pediatrics strategy, labeling, and regulatory documentation.
Before joining Galderma, Caroline worked as a Senior Regulatory Affairs Consultant at EUDRAC FRANCE from November 2009 to October 2011. Prior to that, they held various positions at Allergan Pharmaceuticals. From 2005 to 2009, they served as the Senior Regulatory Affairs Manager for Neuroscience, Dermatology, and Ophthalmology, where they provided input on regulatory strategy and coordinated regulatory activities for new product development and registration in the EU. From 2002 to 2005, they worked as the European Regulatory Affairs Manager for Ophthalmology, managing EU regulatory activities for two studies. And from 1999 to 2002, they worked as the Regulatory Affairs Manager for France and Africa, overseeing registration activities and submissions.
Caroline Robo (Fesquet) began their career as a Pharmacien Affaires Réglementaires at CHAUVIN (B&L) from June 1998 to February 1999, where they gained experience in updating MAAs and validating promotional documents.
Overall, Caroline Robo (Fesquet) has demonstrated expertise in regulatory affairs across multiple companies and therapeutic areas throughout their career.
Caroline Robo (Fesquet) began their education in 1991 at the University of Montpellier, where they pursued a Pharm.D. degree. Caroline successfully completed their studies in 1998, becoming a Docteur en Pharmacie specializing in the field of Industrie. Following this, in 1998, they enrolled at the University of Lille 1 Sciences and Technology to pursue a DESS degree in EU Regulatory Affairs. Their time at this institution concluded in 1999.
September, 2020 - present
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