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Charles MAURES

Marly-le-Roi

En résumé

Post-Approval Maintenance Activities on established products for various markets, mainly EU (under centralized procedure) and International :
- Regulatory assessment, preparation of variations
- Management of requests from Health Authorities
- Liaison with affiliates and other global departments to define the overall regulatory strategy

Pharmacist
Regulatory affairs: Lifecycle management in EU & International
Knowledge of regulation of Orphan drug, Influenza and Vaccines

Master in Community law and pharmaceutical regulatory - University Strasbourg 1


Mes compétences :
Industrie pharmaceutique
Pharmacie
Mobile

Entreprises

  • GlaxoSmithKline - Consultant ( Nalys), GRA Specialist on HPV vaccines & RA specialist on CMAC Remediation Task Force

    Marly-le-Roi 2015 - maintenant 2 different projects:
    - Registration specialist for HPV vaccines (submission & coordination of global RA activities (Art.46, Variation, commitments...), especially into clinical topics.
    - Support LOC into their submissions worldwide (Korean authority, TGA...)
    - RA specialist into the CMAC remediation team: define an effective and a suppliable document for each document in the module 3 for all GSK's vaccines in all countries (compliance activity to reinforce the Global GSK view on their current status in each country for each product)

  • GlaxoSmithKline - Consultant, Global Regulatory Affairs, RA Adults & Travellers - HPV & Influenza

    Marly-le-Roi 2014 - 2015 I was involved in 3 projects:
    - Registration specialist for HPV vaccines (submission & coordination of RA activities (Art.46, Variation, commitments...) to manage the Life cycle of Cervarix
    - Clinical regulatory specialist for Seasonal Influenza vaccines (Writing of Regulatory Supportive Document for GDS Update, Writing of Addendum to Clinical Overview, support to update Core Data Sheet...)
    - CMC writing for the Pandemic Influenza vaccines (Update section of Module 3,Scope & Background in the context of technical variation (Type IA & IB, grouped or not)... )

  • NALYS - Principal Consultant in Regulatory Affairs

    Neuilly-sur-Seine 2014 - maintenant Regulatory consultant currently involved in a GSK mission within HPV and CMAC remediation team

  • GSK Vaccines - Influenza Registration Management on Flu Pandemics vaccines, External

    2012 - 2014 - Life Cycle Management (LCM) on Flu pandemic & Pre-pandemic Vaccines (Variations (I & II), follow-up measures and commitment, PBRER and PSUR, licence cancellation, Art. 46, RfM of on agreed PIP, Annual report, participation in the preparation for an upcoming updated files ...) for Europe and support international countries to help us in the registration and in the LCM of their products.
    - Management of time-lines and submission planning for a portfolio, and tracking of commitments.
    - Provide input into specific sections in PBRER, DSUR & for others submissions
    - Interactions with the Authorities, and with internal departments
    - Support, at an international level, the teams locally to help them to maintain their licences
    - Worked within international team, on centralized procedure

  • Altran - Junior Consultant in regulatory affairs

    Vélizy-Villacoublay 2012 - 2014 Four 6-month missions at the same position (GSK Biologicals as consultant in Influenza Registration Management on Flu Pandemics vaccines)

  • Alexion - Pharmacien Affaires Réglementaires Junior (Regulatory affairs specialist, junior)

    Courcouronnes 2012 - 2012 - Preparation of various European submissions for (Variation type II, IA, IB, Commitment, PALC process, PSUR…)
    - Clinical Trial Application
    - Regulatory intelligence
    - Update a patient/ prescriber leaflet (in a context of a RMP)
    - European control advertising

  • Alexion Europe - Intership in Regulatory Affairs, Alexion Europe

    Courcouronnes 2012 - 2012 -Update of an IMPD
    - Preparation of various European submissions for Variation type II, IA, IB, Renewal, PSUR, linguistic review…
    - Support on labelling, update of a GDS
    - Coordination and finalization of a readability testing
    - Preparation of Slideset
    - Clinical Trial Application
    - Regulatory intelligence

  • Bristol-Myers Squibb - Intern in Operational Marketing Access

    Rueil-Malmaison cedex 2011 - 2011 - Preparation of communication tools for the launch and the referencing at the hospital for a new oral anti-coagulant (Apple Apps, Comparison guide )
    - Preparation of a training for the medical representative
    - Presentation and lead a part of the training for the medical representative

  • Chu Haut Lévèque - Internship in sterilization (externe en stérilisation)

    2011 - 2011 Update of the SOPs for sterilization process and Quality audit of sterilization process, medical device traceability and presentations of audit findings to the department

  • Chu Pellegrin CCLIN - Internship in a Center against the Nosocomial infection (externe au CCLIN)

    2010 - 2011 Regulatory intelligence about nosocomial infections, bibliography, quality audit on the laboratory of analysis (Réalisation de la veille sanitaire des infections nosocomiales, et réalisation d'un audit de contrôle qualité des laboratoires d'analyses en présence de Bactéries Multi Résistantes.)

  • Pharmacie de la Chapelle- ARCACHON - Etudiant (student job in a pharmacy)

    2005 - 2008 during 3 summers within the same pharmacy

  • Ocp répartition - Pharmalien (call center, student job)

    SAINT OUEN 2004 - 2011 - Taking orders
    - Complaint management
    - Providing information and advice
    - Improve the relation with the customer
    - Help the customers to solve his problem

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