Adélie Germain - WIZBII Adélie Germain ha pubblicato il suo profilo professionale su WIZBII. A G

Adélie Germain

Regulatory Product Manager at Sanofi Pasteur

33 anni • Lyon

Riepilogo

Currently Regulatory Product Manager at Sanofi Pasteur, I mostly work on th regulatory strategy for my products portfolio. I am involved in the preparation of regulatory submission in France and in the international area for these products. After my temporary contract, I would like to have a job in line with the one I have for now, within Regulatory Affairs.

Competenze

Regulatory AffairesPharmaceutical Industry

Esperienze

Regulatory Product Manager

10-2015 - OraServizi per la personaRegulatory Product Manager for marketed products: vaccines, human and equine immunoglobulins • Management of a product portfolio: products marketed through Marketing Authorization, Temporary Authorization for Use or Export Declaration • Regulatory Submissions: - Europe: preparation of variations in MRP, answers to questions - Canada: variations, answers to questions, Yearly Biologic Product Report - US: answers to questions • Contact with Health Authority: meeting with ANSM, response to questions in the context of an inspection • Liaise with local affiliates, CMC team and Industrial Operations in the frame of answers to questions from Health Authorities in the international area

Apprenticeship in Regulatory Affairs

09-2014 - 09-2015 Servizi per la persona• Preparation of regulatory submission to Health Canada for a marketed product line (CMC variations, labelling variations, YBPR, answers to questions) and redaction of the associated intern working instruction • Regulatory submissions for a product under development (Clinical Trial Application, IND) • Liaise with local affiliates, CMC team and Industrial Operations in the frame of answers to questions from Health Authorities in the international area

Internship, Regulatory and Medical-economic Affairs in a CRO

04-2014 - 08-2014 Servizi per la persona• Regulatory Affairs: submission of a variation on a CEP to the EDQM, application for an advertising visa for a drug product (ANSM), writing of a dossier for the CE marking of a medical device • Medical-economic Affairs: writing of a dossier for the inscription of a drug product on the list of pharmaceutical specialties reimbursable under social insurance

Internship in a cell-based assays laboratory

04-2013 - 05-2013 Chimica / Biologia / Agronomia• Assistance in organizing a cell-based assays laboratory • Training in cell culture methods in compliance with GLP

Livelli di formazione

Université Claude Bernard Lyon1

2013 - 2015 Lyon, RhôneServizi per la persona• 1st year: project management (pricing and reimbursement procedures for drug product in France), life cycle of health products, galenic and cosmetic technology, quality and professional practice • 2nd year: writing of a marketing authorization application dossier (modules 1, 2 and 3), regulation of Health Product Further education in management by the EM Lyon Business School

Université de Poitiers

2010 - 2013 Poitiers, Vienne

Le mie qualità

Comunicatore/trice
Indipendente
Perseverante
Spirito di squadra

Lingue parlate

  • Francese

    Madrelingua

  • Inglese

    Avanzato

  • Tedesco

    Elementare

Trasforma il futuro in successo.
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