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Julie BEAUGRAND

LES ULIS

En résumé

Pharmacist specialised in EU Regulatory Affairs with broad experience in the Centralised Procedure (Registration, lifecycle management, development) as well as, in a less extent, in the Mutual Recognition Procedure, in the Decentralised Procedure and in national procedure (France).
I am interested in working on biologicals products and/or on products used in immunology/oncology. I like regulatory strategy, learning as well as facing new challenges.

Mes compétences :
Affaires réglementaires
Regulatory Affairs
Clinical trials
Essais cliniques

Entreprises

  • LFB Biomédicaments - Regulatory Affairs Pharmacist

    LES ULIS 2014 - maintenant - Lifecycle management for a product registered via the Centralised Procedure.
    - Lifecycle management for products registered via MRP and national procedures.

  • Bayer HealthCare Pharmaceuticals - Regulatory Affairs Specialist

    Montville 2013 - 2014 CDD d'avril 2013 à fin mars 2014:
    - Assurer la soumission auprès des autorités de santé des demandes d’études cliniques en France et de leurs amendements.
    - Constituer les dossiers nécessaires à l’obtention des autorisations de mise sur le marché et à leur mise à jour en France.

  • Procter&Gamble - Regulatory affairs Pharmacist

    Asnières-sur-Seine 2010 - 2010 Registration of OTC medicinal products via Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) in Central and Eastern Europe.

  • Schering-Plough Europe, Brussels (Belgium) - Manager, EU Regulatory Affairs

    2007 - 2009 Regulatory affairs for Centrally approved products in Hepatology and Oncology.
    Lifecycle management and regulatory regisration strategy for biological products.

  • Bristol-Myers Squibb International Corporation (Belgium) - Associate Manager, EU Study Start Up

    2007 - 2007 Clinical trials in the EU (Preparation of EU documents for submission of the initial clinical study package, of substantial amendments and of end of trial forms, in collaboration with other functional teams).

  • Schering-Plough Europe, Brussels (Belgium) - Manager, EU Regulatory Affairs

    2001 - 2006 Regulatory affairs for Centrally approved products in Primary Care area (Allergy, Respiratory).
    Registration of new medicinal products, regulatory regisration strategy, lifecycle management.

  • Maco Pharma - Regulatory Affairs Pharmacist

    2000 - 2001 Lifecycle management for nationally registered medicinal products (infusion solutions).

  • Afssaps - Regulatory Affairs Pharmacist

    Saint-Denis 1998 - 1998 - Pharmaco-Toxicological-Clinical Unit (3 months)
    - Import/Export Unit (6 months)

Formations

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