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Stephanie REDONDI

ANDRÉSY

En résumé

KEY SKILLS

Regulatory

*National and international dossier writing and submission,
D 91/414/EEC (Chemical and Microbial Plant protection Products), Regulation (EC) n° 2003/2003 (Fertilizers), Directive 98/8/EEC (Biocide Products), Regulation (EC) n° 1906/2007 (REACH/Chemical substances), Regulation 648/2004/EC (Detergent), GHS, Organic farming regulations
*Follow-up of dossiers after submission
*Meetings with member states officials

Classification and Labelling

*Participation to ECB (European Chemical Bureau) meetings. *Defence and discussion of classification proposals for active ingredients
*Labelling and MSDS writing and updates

Toxicology

*Toxicological evaluations: operator, worker and bystander risk assessments.
*Involvement in Medical surveillance programs
*Monitoring and follow-up of toxicological studies
*Writing, review and peer-review of the toxicological parts of the registration dossiers

Communication and liaison

*Participation to IUPP (French Industrial Syndicate for Plant Protection Products) working groups (operator exposure, operator safety)

* Member of IBMA (International Biocontrol Manufacturer Association)
*Member of OECD (Organization for Economic Cooperation and Development) working groups for reviewing guidance documents
*Numerous contacts with scientists, consultants, laboratories and European countries officials

Mes compétences :
Affaires réglementaires
Homologation
Regulatory Affairs

Entreprises

  • Nufarm SAS - EU projects regulatory manager

    2009 - maintenant European project coordinator

    *For allocated molecules, responsible for defining the regulatory strategy and for ensuring the coordination of the studies to be done, the writing of the dossier, the follow-up after submission
    * Budget supervisor for projects and studies in connection with the allocated molecules
    * Monitoring of the toxicological studies
    * Coordination of consultants
    * Building of scientific argumentaires

  • Novozymes - Responsible for European regulatory affairs

    LE PECQ 2006 - 2009 *Responsible for the writing of national and European registration dossiers for microbial plant protection products
    *Responsible for the writing of national registration dossiers for fertilizers
    *Coordination of regulatory projects for all the product lines (plant care, waste water treatment, detergent, aquaculture)
    *Budget supervisor
    *Regulatory follow-up in European countries
    * Coordination of consultants at national levels
    *Contacts with national officials, European officials, consultants.
    * Writing of scientific argumentaires in support to tenders.
    * Classification proposal & Safety data Sheets writing and updating
    * Coordination of actions to be done in the frame of REACH
    * Coordination of actions to be done in the frame of GHS
    * Follow up of the outcomes as part of the Biocides Directive

  • Cerexagri (now UPL) - Registrations Manager

    2000 - 2006 Registration manager

    *Responsible for the writing of national and European registration dossiers
    *Coordination of regulatory projects for specific molecules
    *Budget supervisor for projects and studies in connection with the allocated molecules
    *Regulatory follow-up in allocated countries (UK, Ireland, Belgium then Japan)
    *Contacts with national officials, European officials, consultants.

    Toxicologist

    *Monitoring and follow-up of toxicological studies and issues
    *Operator, worker, bystander, consumer risk assessments
    *Member of ARET (Association pour la Recherche en Toxicologie), IUPP (French Industrial Syndicate for the plant protection products ) working groups, OECD working groups
    *Meetings with toxicologists, consultants, study directors

Formations

Réseau

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