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Lifecycle management on established products for various markets, mainly EU (under centralized procedure) and International (Switzerland, Australia, Brazil....) : - 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 (interested by medical device regulation) Master in Community law and pharmaceutical regulatory - University Strasbourg 1


Current Experience

  • Consultant ( Nalys), GRA Specialist on HPV vaccines & RA specialist on CMC Remediation Task Force
    Since June 2015
    2 different projects: - Registration specialist for HPV vaccines (submission & coordination of global RA activities (Art.46, Variation, commitments, labelling updates...), especially into clinical topics. - Support LOC into their submissions worldwide (Korean authority, TGA...) - RA specialist into the CMC remediation team: define an effective and a suppliable document for each document in module 3 for all GSK's vaccines in all countries (compliance activity to reinforce the GSK view on their current status in each country for each product)

  • Principal Consultant in Regulatory Affairs
    Since December 2014
    Regulatory consultant currently involved in a GSK mission within HPV and CMC remediation team

Past Experience

  • Consultant, Global Regulatory Affairs, RA Adults & Travellers - HPV & Influenza
    December 2014 --- June 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)... )

  • Junior Consultant in Regulatory Affairs
    November 2012 --- December 2014
    Four 6-month missions at the same position (GSK Biologicals as consultant in Influenza Registration Management on Flu Pandemics vaccines)

  • Influenza Registration Management on Flu Pandemics vaccines, External
    November 2012 --- December 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

  • Pharmacien Affaires Réglementaires Junior (Regulatory affairs specialist, junior)
    August 2012 --- November 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

  • Intership in Regulatory Affairs, Alexion Europe
    January 2012 --- July 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

  • Intern in Operational Marketing Access
    June 2011 --- September 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

  • Active Member, writing article to a newsletter
    September 2010 --- September 2011
    BEPIB: it's a student association. The goal of this association was to help the student to create a contact with Pharmaceuticals Companies.

  • Transport of Bone marrow
    December 2010 --- June 2011
    Transport of Bone marrow between two hospitals to provide it for a transplant (France, Germany, USA)

  • Internship in sterilization (externe en stérilisation)
    February 2011 --- May 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

  • pharmalien (call center, student job)
    December 2004 --- May 2011
    - Taking orders - Complaint management - Providing information and advice - Improve the relation with the customer - Help the customers to solve his problem

  • Internship in a Center against the Nosocomial infection (externe au CCLIN)
    October 2010 --- February 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.)

  • Active member of the association ACEPB
    September 2005 --- November 2010
    Responsible partnership gala in 2010, Responsible management of handout 2008 Participation in the organisation of national student events (with more than 400 peoples)

  • Responsible Partnership for a student event Gala 2010
    September 2009 --- March 2010
    Being in touch with different stakeholders into the pharmaceutical domain to create a partnership and to find funding for the GALA 2010 (student event)

  • Stagiaire (trainee in accounts department for Pharmacy)
    July 2009 --- August 2009
    Learning and understanding of an account balance sheet

  • Associative activity : Responsable Polycopié
    September 2007 --- January 2009
    Coordination and gestion of the stock for the student books Ordering the duplicate copy for all students in pharmacy at Bordeaux Liaise with professors to get the original book, liaise with the printer to order the duplicate copy and organize the sale of these books to the students.

  • etudiant (student job in a pharmacy)
    June 2005 --- August 2008
    during 3 summers within the same pharmacy


LinkedIn Assessment :
spanishScientific EnglishPharmaceutical IndustryBiotechnologyRegulatory affairsLifesciencesPharmaceuticsRegulatory submissionsFrenchBiotechnology IndustryTeamworkOPAL (Liquent insight)Biodocumentum (CARS)Lotus NotesPack OfficeVaccinesBiotechnologiePharmaceutiqueSecteur pharmaceutiqueOncologieAffaires r


  • Master in Community law and pharmaceutical regulatory in Master in Community law and pharmaceutical regulatory from Université Louis Pasteur (Strasbourg I) in 2012
  • Pharmacist in regulatory affairs from Université Victor Segalen (Bordeaux II) in 2012

Area / Region



Driving License
  • No