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Fabienne HERBRECHT

Carros

En résumé

Mes compétences :
Dermatology
Biotechnology
SOLID WORKING EXPERIENCE
Rheumatology
Responsible for processing export files
Quality Assurance
Business Development
Audit

Entreprises

  • Virbac - Technico Regulatory Manager, Vaccines Life Cycle Management

    Carros 2015 - maintenant
  • Laboratoires GENEVRIER - Regulatory Affairs Associate

    ANTIBES 2014 - 2014 Regulatory Affairs Associate Laboratoires Genévrier (6 months fixed-term)
    (Sophia-Antipolis, 200 employees, dermatology, rheumatology and biotech products)

    * Submit and follow-up of variations dossiers (Medical Devices and biotech products) ;
    * Prepare responses to Regulatory inquires issued from European Health Authorities ;
    * Provide regulatory guidance to departments or development project teams ;
    * Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations policies
  • Galderma -  Asia Support RA Associate

    Courbevoie 2013 - 2013 ASIA Area Support RA Associate GALDERMA R & D (6 months fixed-term)
    (Sophia-Antipolis, 500 employees, R & D company leader in dermatology)

    * Regulatory Corporate Support for partners/affiliates in Asia area (medicine and cosmetics) ;
    * Constitute, submit and follow-up of renewal and variations dossiers ;
    * Responsible for processing export files according to the requirements of every country ;
    * Report compiled registration status to concerned managers at HQ on monthly basis, update RA database with new approvals, regulations, monthly reports ;
    * Regulation monitoring
  • Laboratoire THERAMEX - Regulatory Affairs Associate

    2006 - 2013 Regulatory Affairs Associate International Areas THERAMEX
    (TEVA affiliate, Monaco, 100 employees, pharmaceutical company specialised in Women Health)
    * Support and follow up with agents regarding any requested documents or information for new registration, renewal, variation until submission to HA and receiving approval ;
    * Define regulatory strategy with manufacturing sites and local partners ;
    * Coordinate, prepare, or review regulatory submissions for domestic or international projects ;
    * Provide support to CMC Writing, Business Development, QA, Marketing, Supply and Logistics Departments

    Participate to French Regulatory Affairs Association involving most important pharmaceutical companies Regulatory Affairs colleagues
  • Laboratoire THERAMEX - Quality Assurance Officer

    2001 - 2006 * Monitoring and auditing of products to ensure high standards of quality ;
    * Coordinating the investigation of customer complaints ;
    * Keeping quality documentation up to date ;
    * Ensuring products comply with legislation and quality assurance codes
  • Laboratoire THERAMEX - Clinical Research Associate

    1995 - 2001
  • FDM PHARMA - Clinical Research Associates Coordination

    1993 - 1995 Clinical Research Studies Coordination FDM PHARMA
    (Sophia Antipolis, 150 employees, CRO)
  • FDM PHARMA - Clinical Research Associate

    1993 - 1993

Formations

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