Freelancer profile translated to English.
Back to original languageAbout Kamilia-Lynda
Pharmaceutical Regulatory Affairs Consultant, I support health industries in regulatory compliance, ensuring market access and maintenance of products.
With expertise covering all health products, I have worked within international groups, where I contributed to high-impact strategic projects.
🔹At Septodont, I participated in change coordination and the management/administration of regulatory databases for various Septodont products (dental practice), in regulatory compliance and the submission of change notifications to the EMA.
🔹 At Sanofi, I led the implementation of vaccines in the EU/Global region on Veeva Vault RIM, worked on variation deployments, and coordinated exchanges between CMC, Quality, and Pharmacovigilance. I also ensured the regulatory submission strategy for Sanofi vaccines to meet health authority requirements (EMA, ANSM).
🔹 Since 2024 at LFB, I have been involved in the management of regulatory variations and the compliance of Marketing Authorizations (AMMs) and conformance/compliance license files (ANSM, PEI). I lead key projects related to water for injection and drafting on various variation groupings of all types (removal of pyrogen testing, update of Ph. Eur., etc.). My role also includes reviewing, proofreading, and approving regulatory documents, updating internal procedures, and analyzing the impact of industrial changes.
With a strategic and operational vision, I master current standards and regulations (GxP, ICH, CLP, Ph. Eur., etc.) and adapt easily, even in new environments. Rigorous and proactive, I am seeking new challenges where I can leverage my expertise in regulatory projects.
📍 Based in the Paris region, I am available to discuss your needs.
French
Native or bilingual
English
Native or bilingual
Arabic
Native or bilingual
Remote only
Primarily works remotely
Experience
- LFB PharmaCMC Regulatory Project ManagerPHARMACEUTICALS INDUSTRYSeptember 2024 - Today (1 year and 9 months)- Writing of Marketing Authorization Applications (MAA) in ENNOV READI for LFB products (e-CTD and IMPD)- Management of variations and various CMC projects (Water for Injection, removal of pyrogen testing, update of European Pharmacopoeia Monograph...)- Compliance of MAA compliance files and conformance license files (ANSM and PEI)- Review, proofreading, and approval of regulatory documents- Response to health authority questions- Updating internal procedures- Strategy for operational implementation of MAAs in batch records- Opening and monitoring of industrial change requests and impact analysis
- Sanofi PasteurConsultant - Regulatory AffairsPHARMACEUTICALS INDUSTRYFebruary 2023 - Today (3 years and 4 months)Paris, FranceOverseeing the activities of the team working on the remediation of new registrations: new vaccines in the Eurasian zone as well as in the Middle East and AfricaReporting on remediation activities for new registrations and Change Control evaluations & category reviews, respecting deadlinesAnalysis of change control requests (CCR) and extraction of data from databasesLiaison with Product Focal Points (PFP) and affiliates regarding CCRs included in the initial file and regarding dispatched CCRsPerforming theoretical assessments according to country guidelines (reporting/non-reporting variations)Contribution to compliance, notably through real-time monitoring of the Veeva Vault regulatory database and correction of inconsistencies (in addition to STARR/Phenix databases)Communication to stakeholders on the finalization of remediationPrior to dispatch: verification of regulatory assessments/classifications/requirements for Key countries and "Rest of the World" countries using STARR/Guidelines/Position papers (global zone)
- SeptodontRegulatory Affairs Coordination OfficerPHARMACEUTICALS INDUSTRYSeptember 2021 - September 2022 (1 year)Paris, FranceManagement of regulatory data for registrations and their post-MAA follow-up in internal databasesCoordination of changes for drugs and medical devices (change control requests, raw materials related to approvals, packaging components, and product withdrawals)Administration and coordination of XEVMPD – Eudravigilance (declaration and data entry related to new drugs, portfolio data updates and monitoring, liaison with medical affairs) and participation in various RA projects (AOC and Kandinsky Sanofi projects, BREXIT, EU-QPPV...)Reporting activities to pharmacovigilance of all updates related to changes in MAA/certificates/control methods/product summaries for drugs in EuropeAdministration of Septodont regulatory databases Axapta-BDR and ENNOVPerforming periodic quality checks of entered data through extractions on procedures, references, manufacturer data, changes, and impactsTeam training, drafting training documents, support, and answers to technical questionsRegulatory intelligence
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Education
- Master 2 in Drug and Health Product Sciences, specializing in Innovation Protection and Health ManagementParis Saclay2022Le master 2 PIMS a une vision complète de la chaine des produits de santé allant de la découverte à la commercialisation du produit de santé. • Positionnement de la propriété industrielle dans le cycle de développement d'un médicament/DM • Environnement socio-économique des produits de santé • Gestion de projets innovants • Brevetabilité, transfert de technologie et protection de l'innovation (princeps, génériques, biosimilaires, DM, cosmétiques, e-santé et IA) • Affaires réglementaires pharmaceutiques • Accès au marché des produits de santé • Connaissance des bases fondamentales en droit des affaires
- Master 1 in Drug and Health Product Sciences, specializing in Clinical Pharmacology, Pre-clinical Pharmacology, and PharmacokineticsParis Saclay2021La formation "sciences du médicament et des produits de santé" : • Formation d'origine multidisciplinaire autour du développement des produits de santé. • Acquisition des connaissances fondamentales dans un domaine spécialisé. • Connaissance du continuum sur toutes les phases du cycle de vie des produits de santé au travers de parcours recherche et de parcours professionnels en alternance ou non. • Découverte et conception de molécules bioactives. • Enseignement des grands domaines de préoccupation actuelle de la recherche en Pharmacologie. Spécialisation en Pharmacologie: • Pharmacologie pré-clinique du Système Nerveux Central, Pharmacologie pré-clinique du Système cardiovasculaire ; Pharmacologie clinique ; Pharmacocinétique. • Participation à des séminaires incluant des analyses d'articles scientifiques: réflexion à des problématiques méthodologiques avec une analyse statistique des données expérimentales obtenues in vitro ou in vivo.
Certifications
- PharmacovigilanceUmanis2022
- Digital MarketingStaffme Academy2022