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Sophie PERRUCHON

Boulogne-Billancourt

En résumé

I work as senior CMC regulatory affairs manager in the pharmaceutical industry to share all my knowledge and competences gained during these last years, to speed up the process of submission of any marketing autorisation and also to have worthwhile interactions with other departement involved in the life cycle of the Drug product (e.g. production, pharmaceutical development, clinical trial, marketing, 3rd party manufacturer, authorities, affiliates).

Mes compétences :
Chemistry
API
Affaires réglementaires
Quality
Informatique
Santé
Management
Microsoft Outlook
Intellectual Property Law
Quality management
Document management
Develop solutions
Team building
Microsoft Office
ISO 900X Standard
ICH
Develop chemical synthesis
Antibiotics
Adobe Pro 9
Communication
Pharmacie

Entreprises

  • Roche - Technical Regulatory Affairs Manager

    Boulogne-Billancourt 2015 - maintenant

  • Boehringer Ingelheim - Senior CMC International Regulatory Affairs Manager

    Paris Cedex 13 2014 - 2015 -Prepare the worldwide (except US) quality and administrative part of the dossier for new submissions as life-cycle management of existing veterinary products (NP, DCP, MRP) for assigned projects/Antibiotics
    - Coordinate and support National Operative Units for veterinary product registrations by preparing and providing necessary registration dossiers and documentation with regard to the quality and administrative part for antibiotics
    - Responsible to evaluate veterinary product dossiers for regulatory compliance (VICH) and suitability for registration
    - Provide support for the successful update of Central Product Database and regulatory systems
    - Lead/support specific veterinary projects

  • Council of Europe / Conseil de l'Europe - Scientific Administrator Supervisor

    Strasbourg 2008 - 2013 After two years assessing module 3 of CTD of API at the Certification division of the European Directorate for the Quality of Medecines and Healthcare, I gained maturity and enough competences to go on assessing module 3 of CTD of API on my own to grant the certification suitablity for monograph of the European Pharmacopoeia for worldwide manufacturers of active substances (e.g. from fermentation, semi synthetic of chemcial synthesis, with/without TSE/BSE risk) and also to supervise 4-9 young scientifst assistants to implement the certification policies and international guidelines (ICH, EMA, EU directives) and to transfer them my expertise in the regulatory field. My strong background in chemisty was usefull for the analysis of the provided data to be evaluated. I had direct contact with the regulatory contact person of companies and official health authorities staff who participate to the assessment of module 3 within certification division.
    This position required rigour, impartiality, organisation as well as good languages and communication skills. At the certification division I implemented quality management in order to maintain the ISO 9001:2008 cerficate which was renewed in 2012.

  • Council of Europe / Conseil de l'Europe - Scientific Administrator

    Strasbourg 2006 - 2008 I decided to change my carreer orientation and worked at the Council of Europe at the Certification division of the European Directorate for the Quality of Medecines and Healthcare. My work consisted in assessing module 3 of CTD of API to grant the certification suitablity for monograph of the European Pharmacopoeia for worldwide manufacturers of active substances (e.g. from fermentation, semi synthetic of chemcial synthesis, with/without TSE/BSE risk) in compliance with the certification policies and international guidelines (ICH, EMA, EU directives). My strong background in chemisty and in R&D was an asset to evaluate the data provided by the companies. I had to work with other administrators from different nationalities as well as from different professional experiences. I had direct contact with the regulatory contact person of companies.
    This position required rigour, impartiality, organisation as well as good languages and communication skills. At the certification division I implemented quality management in order to maintain the ISO 9001:2008 cerficate which was granted in december 2009.

    http://www.coe.int
    The european directory of quality of medecines (EDQM, http://www.edqm.eu) is a world leader in the establishment of high quality standards for human, veterinary medicinal products and healthcare recognised throughout Europe, and covering the entire range of raw materials used to produce these medicines which are of common interest to European countries. It contributes to the basic human right of access to good quality medicines and thus promote and protect human and animal health by:
    - establishing and providing users with official standards for the manufacture and quality control of medicines applicable in all the signatory states of the Convention for the elaboration of a European Pharmacopoeia,
    - setting up privileged collaboration with observer states at the European Pharmacopoeia Commission, and
    - organising a network of Official Medicines Control Laboratories to collaborate and share expertise.
    EDQM Certification division is responsible for implementing the procedure for certification of suitability of monographs of the European Pharmacopoeia. This division has been given specific premises in the EDQM, which are equipped to guarantee the strict confidentiality of the information in the dossiers assessed during the meetings held in Strasbourg. Only experts and members of the division have access to these premises, which are protected by an electronic security system.

  • Université Paris-Sud - Chargé de recherche

    Orsay 2004 - 2006 www.u-psud.fr/biocis
    Unité de chimie thérapeutique BioCIS : Dévéloppment de nouveaux composés possèdant des activités pharmacologiques
    Recherche et dévéloppement de nouveaux composés antitumoraux:
    synthèse totale multi-étapes
    caractérisation
    purification
    Livraison aux laboratoires clients

  • Merck KGaA - Assistante de recherche + doctorat

    Darmstadt 1999 - 2003 www.merck.com
    Unité de recherche et dévéloppment de produits naturels à visée cosmétique.
    synthèse parallèle de bibliothèque de flavonoides
    purification
    recherche d'activités cosmétiques et pharmaceutiques
    étude relation structure activité

  • Haupt Pharma Berlin Allemagne - Assistante de recherche

    1998 - 1998 www.haupt-pharma.com
    Développement galénique de médicaments génériques:
    Mise au point de nouvelles formulations galéniques d'antibiotiques pour des clients français

  • Roche - Technicienne stagiaire

    Boulogne-Billancourt 1996 - 1996 www.roche.com
    unité de dévéloppment de catalyseurs:
    mise au point de synthèse de nouveaux ligands phosphines

Formations

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