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Sandrine SEGURA GOZZINI

Marne La Vallée Cedex 2

En résumé

Mes compétences :
Topicals, orals, biologicals, cosmetics, OTC, MD
Leadership and management skills
International environment
Supplier management
Regulatory compliance
Pharmaceutical development
CTD module 3
Projct and portfolio management

Entreprises

  • Nestlé - Product Development Project Manager/CMC expert

    Marne La Vallée Cedex 2 2006 - maintenant : GALDERMA R&D/ Nestlé Skin Health, Sophia Antipolis (F)
    : Senior Product Development Project Manager / Senior CMC Expert
    Key responsibilities as Product Development Project Manager:
    * Coordinated the operational activities including formulation, analytical development (quality control, packaging, stability, microbiology) and pilot manufacturing for drug substances and drug products within Pharmaceutical Development department or with subcontractors or with license partners
    * Organized the manufacturing availability of preclinical and clinical supplies
    * Ensured technology transfer from R&D to the manufacturing sites for clinical and registration batches
    * Participated in the overall project plan optimization and consolidation (timelines, man-days, budget) and proactively evaluated risks at operational level and built contingency plans for discussion
    * Assured regular communication and reporting between project and operational team

    Key responsibilities as CMC Expert:
    * Established the pharmaceutical regulatory strategy ;
    * Contributed to the preparation of regulatory documentation (briefing packages, investigator's brochures, IND/IMPD, CTD, IDE, PMA, labeling documents), answered questions from Authorities during the rev iew process including geographical roll-out, attended Scientific Meetings with Health Authorities (EMA , FDA etc.) and pre-approval inspections
    * Contributed to the evaluation of new opportunities (due diligence) in the Pharmaceutical field

  • Nestlé - Formulation Development Team Leader & Formulation Laboratory Deputy Manager

    Marne La Vallée Cedex 2 1999 - 2006 : GALDERMA R&D/ Nestlé Skin Health, Sophia Antipolis (F)
    * Managed a team of 6 people to develop formulations for cosmetic and pharmaceutical products
    * Coordinated intellectual property in collaboration with the Intellectual Property Department

  • Nestlé - Researcher

    Marne La Vallée Cedex 2 1997 - 1999 :

Formations

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