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Caroline DESURMONT-RUCHAUD

Paris

En résumé

Senior Executive with 21 years experience acquired both in academic and multinational pharmaceutical & biotech companies (Pasteur Institute, Hopital Lariboisiere, Rhone-Poulenc Rorer, Servier, Gencell-Serono, Sanofi-Aventis & Genzyme)
Successful track records in management of production, research & development programs, including 4 years of Project Direction and more than 10 years of Regulatory expertise.

Regulatory talent deployed through the structuration of the development of a high quality, global regulatory strategy through pre-IND to launch, to deliver a competitively differentiated, value-added sustainable product launch.
Regulatory Areas of expertise include small molecules, GMO, Advanced Therapy, Gene Therapy and Biotech regulations
Immunology / Orphan Indications and Biologics, with a worldwide experience gathered through successful regulatory submissions and registrations of small molecules/biologics in different therapeutic areas.

Skills:
Acknowledged industry thought leader with extensive network across the industry and its regulators.
Influential leadership style with expert-level skills: Cultivator of high-performance cross-functional teams.
Advanced interpersonal, persuasive communication skills combined with passion to identify and solve problems by developing strategic insights and pragmatic solutions
Strongly recognized for “never give-up” attitude striving for results that leads projects to completion.

Strong commercial focus supported by key skills and understanding of the value-based requirements in current pharmaceutical environment.
Strong self-driven and independent project management and negotiation ability to articulate scope-schedule-budget, delivering high-impact cost-effective sustainable solutions
Adept strategic thinker coupled with successful record of implementation of global regulatory process changes& organization changes
Seeker of joy and self-realization at work.

Mes compétences :
Affaires réglementaires
Biotechnologies
Développement
Management
Management de projet
Pharmacie

Entreprises

  • Sanofi - Head of Global Regulatory Diabetes and Cardiovascular

    Paris 2016 - maintenant In charge of the strategy for regulator development and registration of the diabetic and cardiovascular products for Sanofi

  • Sanofi - Global Regulatory Affairs, Chief of Staff / Attaché

    Paris 2014 - 2015 - In charge of representating the Global Regulatory Affairs Head within all Governance bodies
    - Definition and implementation of global Regulatory Strategy, long-range plan projection,
    - Definition and deployment of governance
    - Driving of Strategic Excellence.
    - Ensure Effective communication across the Regulatory Community an across internal/external stake-holders, education and training of partners
    - Creation and implementation of outsourcing/offshoring strategies for Global Regulatory Affairs

  • Genzyme - Regulatory Head for MS and Cell therapy units

    Saint-Germain-en-Laye 2011 - 2013
    Head of global regulatory development, leading a team who succesfully submitted in more than 30 countries and registered in more than 15 so far Aubagio in the Multiple sclerosis field.

    Head of a global regulatory development team in charge of submission of a gene therapy compound for Critical Limb Ischemia.

    Lead of several regulatory due dilligences in the area of gene/Cell therapy

  • Sanofi - Head of a cardiovascular and gene therapy regulatory

    Paris 2010 - 2011 Leading a team in charge of submission of a gene therapy compound for Critical Limb Ischemia.
    Lead of several regulatory due dilligences in the area of gene/Cell therapy

  • Gencell - Aventis Pharma - Project Direction In Gene Therapy / Project Director, Cardiovascular & Anti Angiogenesis

    2003 - 2004 In charge of the definition of the Phase 2 development program in cardiovascular gene therapy.
    In charge of the definition of the pre-Phase 3 program for an pro-angiogenic factor.

    In charge of the coordination of discovery/preclinical/QC/QA/GMP manufacturing/clinic and Reg. Affairs team for transition of Lead discovery to Phase 1 anti-angiogenic mAb.

  • Merck Serono - Program Director For Orphan GPCR Molecules

    Lyon 2001 - 2002 Definition of the research program strategy for Genset (Merck Serono)
    Deorphanisation strategy, lead identification, implementation of project management & project planning procedures
    Transversal coordination of 60 FTEs working in bio-informatics, genotyping, proteomics, molecular biology, in silico analysis, business development...
    => Selection of 2 lead candidates for entry into development

  • Merck Serono - Genotyping Development Group Leader

    Lyon 2000 - 2001 Production platform: Operation Direction of a high-throughput genotyping platform.
    Management of 40 FTEs in direct
    Implementation of a high throughput genotyping method and integration within existing bio-informatics procedures lead to 20% cost-reduction in production and increase of 30% of genotyping capacities

  • Servier - International Clinical Trial Manager

    Suresnes 1998 - 2000 Organization, follow-up and documentation of preclinical and clinical studies in the anti-diabetic field, in coordination with drug-discovey, PK/PD and toxicological departments.
    Management of CROs and academic centers for pharmacological studies.
    => Successfull transition of an anti-diabetic compound from Phase 1 to Phase 2
    Successful Phase IV program after a recall in metabolic syndrom

  • Hopital lariboisière - Institut des Vaisseaux et du Sang - Post-doctorate

    1998 - 1999 Succesfull engineering of a knock-out mouse for the human gpIX haemostatic protein

  • Institut Pasteur - Ph.D. Cardiovascular and Gene Therapy

    Paris 1994 - 1998 Thesis subject:
    Evaluation of the role of apolipoprotein E in cardiovascular gene therapy following various viral gene transfers.

    PhD successfully passed with the highest grade of pass

Formations

  • London Business School

    Londres 2014 - 2014 Leadership campus program

  • HEC

    Jouy En Josas 2002 - 2002 Degree in PM

  • IFSBM

    Villejuif 1994 - 1998 Degree in Medicinal treatment, Biomedical/Medical Engineering, Endocrinology, Cellular Biochemistry and neurobiology

  • AgroParisTech ABIES (Paris)

    Paris 1994 - 1998 Ph.D cardiovascular & gene therapy

  • UCSF University Of California, San Francisco (San Francisco)

    San Francisco 1993 - 1993 Master of Sciences Bacteriology and Biotechnology

  • AgroParisTech

    Paris 1991 - 1994 Diplome d'ingénieur généraliste

    Graduated with honors in
    - Majors: Biology, Biochemistry, Food and Nutraceuticals, Gene & cell Therapy
    - Minors:Agronomy, Project Management, Business Sciences, Organizations

Réseau

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