Anne-Claire Ginestet's Email Addresses & Phone Numbers

Regulatory implementation manager @ From February 2015 to Present (11 months) Data Analyst @ GlaxoSmithKline, London, United Kingdom - Global Regulatory Operations Change management and data remediation project (Regulatory Affairs Area) ➢ Follow-up the implementation of the new version of the database (IT development, User Acceptance Testing review) ➢ Presentation of change process following strategic decision, regulation...

Regulatory implementation manager @ From February 2015 to Present (11 months) Data Analyst @ GlaxoSmithKline, London, United Kingdom - Global Regulatory Operations Change management and data remediation project (Regulatory Affairs Area) ➢ Follow-up the implementation of the new version of the database (IT development, User Acceptance Testing review) ➢ Presentation of change process following strategic decision, regulation change or business alignment ➢ Data remediation on a worldwide project to ensure data compliance. ➢ Analyse and organise the implementation of Medical Devices data in the database. ➢ Working with an India Offshore team From May 2013 to December 2014 (1 year 8 months) London, United KingdomProject Manager @ GlaxoSmithKline, France – Pharmaceutical Regulatory Affairs Department Change management in a Local Operating Company (LOC) following implementation of a new global regulatory database. ➢ Workload evaluation and project management to lead the French data remediation. ➢ Collaboration with the global and the local company in different Business Unit to understand local needs align with global requirements. ➢ Validation/Correction of numerous data ➢ Change management to switch off the former local database and maintain the new global database o Training the local team o Mapping Activities/responsibilities at a LOC level o Update local Standard Operational Procedure (SOP) in accordance to the global SOP From June 2011 to April 2013 (1 year 11 months) Project Manager @ ALTRAN Research, Paris, France Coordinate an innovative sustainable R&D Project ➢ Coordinate a technological watch to implement a sustainable development methodology ➢ Leading and Drafting minutes of weekly meeting, Monthly Oral presentation to scientific direction ➢ Follow up individual (10 peoples) and project objectives From January 2011 to June 2011 (6 months) R&D engineer @ L’ORÉAL, France – Predictive Method & Models Development department Human reconstructed skin model evaluation through genotoxicity assay validation ➢ Coordinate a new human reconstructed skin model study related to applications in L’Oreal Research departments o Need analysis, scheduling and coordination of experimental design between entities o Experimental work in biological laboratory o Data compilation and analysis, Writing a document on the model performance for the scientific direction ➢ Technical test realisation for an international validation study of a genotoxicity assay on human reconstructed skin o L’Oreal technical referent to share progress and results with the international working group (P&G, Henkel, IIVS) o Review harmonised protocol for scientific publication o Collaboration with statisticians on statistical methods to analyse various and numerous data From August 2008 to December 2010 (2 years 5 months) Aulnay-Sous-Bois Area, FranceInternship @ Pharmaceutical lead optimisation ➢ Literature review, Synthesis and Characterisation of chemical molecules ➢ Study of the relationship between chemical structure and biological activity to select chemical functional group From February 2008 to August 2008 (7 months) Internship @ Market analysis, Start-up expansion ➢ Market analysis to introduce recombinant protein in cosmetic formulation → Launch SIF Cosmetics in 2009 ➢ Screening Barley production to select the most efficient plant From February 2007 to August 2007 (7 months) Internship @ Sunscreen effectiveness evaluation ➢ Evaluate a sunscreen cream and compare two biological models (keratinocytes growing as monolayer versus reconstructed skin model) ➢ Establish an image analysis platform to automated sample capture and results analysis. o Improve image quality and acquisition speed o User training, writing guidances From June 2006 to December 2006 (7 months) Aulnay-Sous-Bois Area, FranceNational Graduate School of Chemistry, Paris, France, Chemistry, Diplome d'Ingenieur Chimie (i.e Master degree) @ Ecole nationale supérieure de Chimie de Paris From 2007 to 2008 The National Graduate School of Chemistry, Montpellier, France, Chimie, 3rd and 4th academic year @ Ecole Nationale Supérieure de Chimie de Montpellier From 2004 to 2006 Two years of undergraduate intensive education in selective preparatory classes @ Ecole nationale supérieure de Chimie de Rennes From 2002 to 2004 High School Diploma @ Lycée Pierre de Fermat From 2001 to 2002 Anne-Claire Ginestet is skilled in: Validation, R&D, Pharmaceutical Industry, FDA, Chemistry, Sop, Cross-functional Team Leadership, Biotechnology, Regulatory Affairs, Quality Assurance, Quality System, Analytical Chemistry, Project Management, Lifesciences, Affaires réglementaires, Secteur pharmaceutique, Leadership d'équipe multifonctionnelle, SOP