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Adélie Germain

Regulatory Product Manager at Sanofi Pasteur

28 years • Lyon

Summary

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.

Skills

Regulatory AffairesPharmaceutical Industry

Experience

Regulatory Product Manager

10-2015 - NowPersonal servicesRegulatory 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 Personal services• 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 Personal services• 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 Chemistry / Biology / Agronomy• Assistance in organizing a cell-based assays laboratory • Training in cell culture methods in compliance with GLP

Education & training

Universite Claude Bernard Lyon1

2013 - 2015 LyonPersonal services• 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

My qualities

Communicating
Independent
Persevering
Team player

Languages spoken

  • French

    Native language

  • English

    Professional

  • German

    Basic