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
LIQUENT, a PAREXEL® Company
Regulatory implementation manager
February 2015 to Present
May 2013 to December 2014
London, United Kingdom
June 2011 to April 2013
January 2011 to June 2011
August 2008 to December 2010
Aulnay-Sous-Bois Area, France
February 2008 to August 2008
February 2007 to August 2007
June 2006 to December 2006
Aulnay-Sous-Bois Area, France
Ecole nationale supérieure de Chimie de Paris
National Graduate School of Chemistry Paris France Chemistry Diplome d'Ingenieur Chimie (i.e Master degree)
2007 to 2008
Ecole Nationale Supérieure de Chimie de Montpellier
The National Graduate School of Chemistry Montpellier France Chimie 3rd and 4th academic year
2004 to 2006
Ecole nationale supérieure de Chimie de Rennes
Two years of undergraduate intensive education in selective preparatory classes
2002 to 2004
Lycée Pierre de Fermat
High School Diploma
2001 to 2002
What company does Anne-Claire Ginestet work for?
Anne-Claire Ginestet works for LIQUENT, a PAREXEL® Company
What is Anne-Claire Ginestet's role at LIQUENT, a PAREXEL® Company?
Anne-Claire Ginestet is Regulatory implementation manager
What industry does Anne-Claire Ginestet work in?
Anne-Claire Ginestet works in the Pharmaceuticals industry.
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