Sophie PERRUCHON

En résumé

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

• Université Rennes 1

  Rennes 1990 - 1998 chimie

• Lycée Francois Rabelais

  St Brieuc 1985 - 1990 mathématiques

Réseau

• Alain EUZEN

• Anne DE VILLEROCHÉ (TOULLEC)

• Anne MITERNIQUE

• Cristelle DELABY

• Marie-Paule DOL?DEC

• Philippe WOHLGEFARTH

• Samuel JANNEL

• Stéphane GAYET

• Thierry MARI