Regulatory Affairs Manager

• May 2022 - Present

Regulatory Site Officer

• Jan 2022 - Apr 2022

RA Pharmacist Consultant

• Nov 2019 - Apr 2022

Biologicals Regulatory Affairs Consultant

• Jul 2021 - Dec 2021

CMC Regulatory Compliance Consultant

• Jan 2020 - Jun 2021

Objective(s): CMC Variation Management of Drug Product and Active Pharmaceutical Ingredient (European and Worldwide division). Missions: - Support for project group meetings ; - Follow-up of actions with the manufacturing sites for the provision of the data necessary for the redaction of the variations (manufacturing validation reports and/or analytical reports, stability study, etc.) in accordance with the defined regulatory prerequisites ; - Verification of the adequacy of the data provided with the regulatory strategy ; - Assessment of regulatory differences and impacts between recorded files and manufacturing site procedures ; - Redaction of the CTD sections (module 3) of the MA dossier Show less

Regulatory Affairs Apprentice

• Sep 2018 - Sep 2019

Objective(s): - Redaction of variation files (active ingredient and finished product - eCTD format) for submission to the authorities and monitoring of the approval and implementation (national procedures and relay for transposition of European procedures) ; - Active support for industrial affairs ; - Validation of texts of packaging articles (SmPC, manuals, labeling, primary and secondary packaging) for launching new products ; - Regulatory watch and monitoring Missions: - Redaction of variation files (foreseen and unforeseen art.5) type IA / IAin / IB ; - Redaction of conditioning articles (RCP, notices, labeling, primary and secondary packaging); - Validation of marketing support for launching a new range of products ; - Participation and management of regulatory projects (variations impacting several products, NeeS and CTD files digitization project …) ; - Support for industrial affairs (implementation and authorization of Changes Control…) ; - Launch of a new product (module writing, gap analysis ...) Show less

CMC Regulatory Affairs Officer - Trainee

• May 2018 - Aug 2018

Objective(s): CMC Variation Management of a Cardiac Product Line for the International Division of a Pharmaceutical Company Missions: - Gap analysis current / proposed ; - Redaction of variation files (type IA / IAin) ; - Preparation of technical and administrative documents (modules 1, 2 and 3) ; - Submission of variations / Follow-up and answers to questions from the authorities ; - Generation of Approved Product Quality Characteristic for the products of the International Division (Regulatory Affairs/Production-Quality Liaison Document) ; - Automating Excel file for the management of variation : programming macros via Virtual Basic for Application (Microsoft) Show less

Regulatory Affairs Assistant

• Sep 2017 - Aug 2018

Objective(s): Preparation of marketing authorization sections and regulatory documents for application and marketing of digestive drugs for the African and Indian market Missions: - Redaction of the modules (1, 2 and 3) of AMM files ; - Development of primary and secondary packaging ; - Preparation of submission to local authorities (India, Africa) ; - Writing of leaflets and training materials for health professionals ; - Writing of promotional information Objective(s): Preparation of marketing authorization sections and regulatory documents for application and marketing of digestive drugs for the African and Indian market Missions: - Redaction of the modules (1, 2 and 3) of AMM files ; - Development of primary and secondary packaging ; - Preparation of submission to local authorities (India, Africa) ; - Writing of leaflets and training materials for health professionals ; - Writing of promotional information

Stagiaire Pharmacien

• Jun 2017 - Mar 2018

Stage d'Assurance Qualité Opérationnelle au Département de Production des Antigènes - Flux Monolayers/Ovoculture : Projet de réaménagement des autoclaves de stérilisation et de désinfection Analyses de risque pour les cycles de décontamination de DASRI en fonction des agents pathogènes manipulés en production Gestion du projet et d'équipe Rédaction et pilotage d’essais pour étude de faisabilité Rédaction de procédures, protocoles d'essais et de fiches d’analyses Stage d'Assurance Qualité Opérationnelle au Département de Production des Antigènes - Flux Monolayers/Ovoculture : Projet de réaménagement des autoclaves de stérilisation et de désinfection Analyses de risque pour les cycles de décontamination de DASRI en fonction des agents pathogènes manipulés en production Gestion du projet et d'équipe Rédaction et pilotage d’essais pour étude de faisabilité Rédaction de procédures, protocoles d'essais et de fiches d’analyses

Préparateur de commandes

• Mar 2017 - Jun 2017

Mission - Junior Pharma Industrie Lyon Mission - Junior Pharma Industrie Lyon

Externe en Pharmacie

• Jan 2016 - Sep 2016

Stage Hospitalo-Universitaire / Service de Biochimie Clinique - Coordination entre services médicaux (hépatologie, réanimation néonatale) et de biochimie clinique - Mise en place et réalisation d’audits qualité - Réalisation de tests biologiques et de cas cliniques - Validation de méthodes d’analyse Stage Hospitalo-Universitaire / Service de Biochimie Clinique - Coordination entre services médicaux (hépatologie, réanimation néonatale) et de biochimie clinique - Mise en place et réalisation d’audits qualité - Réalisation de tests biologiques et de cas cliniques - Validation de méthodes d’analyse

Stagiaire en officine

• 2013 - 2013

3 stages d'application (durée totale : 2 mois) 3 stages d'application (durée totale : 2 mois)

Élève Officier Médecin

• Jun 2011 - Jul 2011

Service de Chirurgie Orthopédique Service de Chirurgie Orthopédique