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Malt Strategy
Malt Strategy
Sabrina GuittardSG

Sabrina Guittard

Global Regulatory Lead | SSU specialist [ CRA

EUR 900/Tag
Toulouse, FR
15+ Jahre
Regulatory submissions and international compliance
Attention to details
Timeline optimization and risk management
Communication and leadership
Flexibility and adaptability to multicultural environments

Durchschnittliche Reaktionszeit: 1h

Über Sabrina

Senior consultant specialized in clinical trial regulations and submission strategy. Starting as CRA, growing in different structures (CROs, Oncology center) with almost 20 years of experience in the pharmaceutical and biotechnological industries. Extensive expertise in oncology and experience in rare disease, at international level.
Biotechnologien
Pharmazeutika

  • Französisch

    Muttersprachlich oder zweisprachig

  • Englisch

    Verhandlungssicher

Vor Ort möglich
Toulouse (bis zu 50 km)

Projekt- und Berufserfahrung

  • Allucent
    Global Regulatory Lead
    MEDIZIN
    Juli 2023 - Januar 2025 (1 Jahr und 6 Monate)
    France
    • Plan timelines for RA/IEC/IRB submissions in 19 countries (US, Canada, EU (CTR), Moldova, Ukraine, Georgia, UK, LATAM)
    • Coordinate the preparation of submissions
    • Ensure appropriate tracking is done on time
    • Review and finalize Master SIS/ICF
    • Oversee Country SIS/ICF.
    Timeline optimization and risk management Communication and leadership Regulatorische Strategie Regulatory submissions and international compliance Gestion de projet
  • Allucent
    Global Submission Specialist
    MEDIZIN
    Januar 2022 - Juni 2023 (1 Jahr und 5 Monate)
    Netherlands
    • Perform CA and EC submissions in Europe under CTR (AT, DE, FR, IT, ES) and CTD (FR, UK, ES, DK, AT, DE, BE, NL).
    • Create Master and country ICF.
    • Acting like SSUM for small studies.
    • Reviewer of SOPs
    Attention to details Communication and leadership Timeline optimization and risk management Regulatorische Strategie Satisfaction client
  • IQVIA Biotech
    Regulatory and Start-Up Specialist
    MEDIZIN
    Juli 2019 - Dezember 2021 (2 Jahre und 5 Monate)
    France
    • Perform site identification and Feasibility
    • Adapt country ICF
    • Prepare and submit CEC packages
    • Advice Regulatory for submissions
    • Submit CNIL notification
    • Create National Grid and negotiate Contract Unique (CU) and other agreements with all sites
    • Submit CU to CNOM via IDAHE2
    • Collect Essential documents
    • Perform QC of CEC/LEC packages for EU countries
    • Lead French LSSU on some studies


    Négociation de contrat RGPD Attention aux détails Conformité réglementaire Coordination de projet
Gesamte Berufserfahrung von Sabrina ansehen

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Ausbildung und Abschlüsse

  • Master of Clinical Research Admin
    Sup
    2006
    Clinical Research Associate Training
  • MSc in Analytical Chemistry and Quality Assurance
    University of Orléans
    2004
    MSc in Analytical Chemistry and Quality Assurance

Fähigkeiten

Regulatorische Strategie
CTMS
Veeva Vault
Négociation de contrats
Monitoring
Coordination de projets

Kategorien