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Sophie RAMUSAT

Paris

En résumé

Mes compétences :
CDS
Packaging
Regulatory Affairs
Prise de décision
Management
Communication
Analyse
CMC
Labelling

Entreprises

  • Parexel - Consultant

    Paris 2017 - 2018 Project Manager responsible for the registration and license maintenance of an international product.
    Work closely with the delivery team, the health authorities and the client.
    Coordinate CMC and Labelling activities for worldwide countries in order to achieve projects within defined timelines and budget.
    Participate to regulatory strategy meetings with the client and manage execution of projects.
  • Parexel - Senior Regulatory Affairs Consultant

    Paris 2015 - 2017 Project Manager responsible for the registration and license maintenance of an international product.
    Work closely with the delivery team, the health authorities and the client.
    Coordinate CMC and Labelling activities for worldwide countries in order to achieve projects within defined timelines and budget.
    Participate to regulatory strategy meetings with the client and manage execution of projects.
  • Allergan - Senior Regulatory Affairs Associate

    Courbevoie 2014 - 2015 Country manager of the French West African countries, the Sub Sahara African countries, Tunisia and Ukraine:

    • Marketed product maintenance: Provide Regulatory support for all the Emerging Markets for assigned products and inputs to project teams via Global Regulatory Teams meetings.
    • New product registration: Preparation of core files for MAA according to local requirements, Collaboration with the CMC team, the Labelling team, the manufacturing sites, the local distributors.
    • Development product: Provide Regulatory support for all the Emerging Markets for product in pre-clinical phase.
  • Allergan - Regulatory Affairs Associate

    Courbevoie 2013 - 2013 In charge of 6 countries in the Middle East:

    New Product Registration:
    Preparation of core files for MAA.
    Work cross-functionally with the CMC team, the labelling team, the manufacturing sites, the local distributors in order to respond to Questions from Regulatory Authorities to gain product approvals.
    Planning and tracking of CMC and Labelling variations during the MAA review to ensure Regulatory compliance.
    Communication of regulatory strategy in support of new product registration, in line with commercial objectives.

    Marketed Product Maintenance:
    Provide Regulatory support for assigned products and inputs to project teams via Global Regulatory Teams.
    Implementation of variations and renewals for the region as well as regulatory activities in support of lifecycle management and maintenance in the region.
  • Genentech - Intern Strategic Labeling Group

    San Francisco 2012 - 2013 • Strategic Labeling: Creation of Core Data Sheet (CDS) for development products, Updates of CDS for marketed products, Creation of Local deviations from the CDS, Collaboration with Product Managers, Clinical, Safety and Pharmacology specialists.

    • Commercial Labeling: Preparation and update of product information for Roche’s common make-up product labeling, Review texts and approve final leaflets and printed components used in drug packaging for printing, Collaboration with Product Managers and Country Managers in Regulatory Affairs in Basel, Artworks Management, and Logistics.

    • Commercial Regulatory Affairs: Regulatory review of promotional pieces as booth panels for US conferences, $250,000 TV ad, radio spots, educational materials and giveaways.
  • Les Laboratoires Servier - Intern in Regulatory Affairs Asian area

    2011 - 2011 Compilation of documents required for clinical trials and registration of drugs in Asian area: China, South Korea, Taiwan, India, Vietnam.
    • Preparation of documents required for the renewal of 11 drugs in Vietnam
    • Preparation and follow-up of variation dossiers
    • Daily videoconference meetings with subsidiaries, preparation of the agenda and writing the minutes
  • Maris Lannelongue Hospital - Pharmacy Extern

    2010 - 2011 Follow up visits of doctors and patients’ treatment in the clinical services : Thoracic Surgery, Cardiac Surgery and
    Resuscitation.
    In charge of the management and the orders of the Pharmacy
  • Charles River - Immunology Analyst

    2010 - 2010 In a bilingual environment, position of analyst in the immunology laboratory :
    • Conditioning of serum & plasma samples, centrifugation, ELISA tests, spectrophotometer analysis and conclusions,
    • Serologic follow up after injection,
    • Stability control, Quality control,
    Trials & tests reporting through written reports in English.

Formations

  • Paris Sud XI-Chatenay-Malabry (Clamart)

    Clamart 2005 - 2012 Master

    International Drug Development and Registration

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