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Alexia BOSQUET

Regulatory CMC Manager at Sanofi Pasteur

32years • Lyon

Summary

As a Regulatory CMC Manager for flu vaccines, I'm responsible for managing all the regulatory CMC aspects throughout the life cycle of the products. My major responsibility is the preparation of the CMC documents for the next flu campaigns (CTD sections, AtoQ from the Health Autorities, regulatory commitments, etc ..) in the framework of the annual strain variation submissions (Northern & Southern hemispheres). I also compile all the relevant information necessary to support other regulatory submissions and I anticipate any delays in pre-defined submissions.

Skills

CMC Regulatory AffairsModule 3 + QOSVaccines Manufacturing Processes And Controls

Education & training

Université Claude Bernard Lyon1

2013 - 2015 Lyon, RhônePersonal services, Design / Civil engineering / Industrial engineering, Marketing, Project / Product management, Design / Civil engineering / Industrial engineering, Chemistry / Biology / Agronomy

Université Joseph Fourrier/ Grenoble, Grenoble (France)

2010 - 2013 Grenoble, France, Grenoble

My soft skills

Team player
Curious
Positive
Thorough

Languages spoken

  • French

    Native language

  • English

    Professional

  • Spanish

    Basic

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