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Colette JACQUET

En résumé

Senior pharmacist with 13 years of combined experience in international Regulatory Affairs and Quality Assurance.

Services either on-site in the area of Lyon or from remote office:
_ guidance, strategy and hands-on support at every stage of product's lifecycle
_ compliance with regulatory and QA requirements
_ flexible and transparent service, tailored to the needs of the client

Regulatory Affairs
- Writing of CMC, Quality parts (Modules 2.3 & 3)
- Audits of MA dossiers and ASMF
- Industrial sites transfers management for API, DP
- Preparation, submission of Marketing Authorization dossiers
- Regulatory liaison, strategic advice, meetings, negotiation with Health Authorities
- Labelling
- Validation of promotional documents

Quality Assurance and Qualified Person responsibility
Registered as QP “Exploitant” on the register of the French Chamber of Pharmacists
- Writing of SOP and departmental processes
- Update of QA documentation for MA holder or French “Exploitant” site
- Preparation for Health Authority inspection
- Qualification and management of manufacturers, distributors

Pharmacovigilance
- PV system supervision
- Safety Data Exchange Agreements
- Medical information handling

Mes compétences :
Variations
Industrial transfers
GMP

Entreprises

  • Consultant - Regulatory Affairs & Quality Assurance - Independent consultant

    2016 - maintenant
  • Consultant - Regulatory Affairs & Quality Assurance - Independent consultant

    2016 - maintenant
  • Consultant - Regulatory Affairs & Quality Assurance - Independent consultant

    2016 - maintenant
  • GlaxoSmithKline - Consultant - Senior Regulatory Executive

    Marly-le-Roi 2014 - 2014 Global Labeling Review – 100 countries
  • Laboratoires Juvisé Pharmaceuticals - Qualified Person Deputy - Regulatory Affairs Manager

    2011 - 2016 Team management
    Post-approval regulatory activities worldwide for various pharmaceutical forms
    Pharmacovigilance
    QP responsibility
    Quality Assurance activities of the Exploitant site
  • Laboratoire Aguettant - Regulatory Affairs Associate

    Lyon 2004 - 2010 Pre-approval and post-approval regulatory activities (CMC, injectable medicines) in European, Middle East and Asian markets
    MRP, DCP procedures
    MA dossiers and ASMF audits
  • Merial - Regulatory Affairs Internship

    Lyon 2003 - 2004 Variations for veterinary vaccines

Formations

Pas de formation renseignée

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