Franck Vigliecca

Franck Vigliecca

Senior Publisher Manager

Key Knowledge Areas:

Publishing of Regulatory Registration Dossiers
- IND, NDA, MAA (MRP/DCP/CP/NP), IDE, PMA, DSUR, ACTD Dossiers
- Zones : America (North US, CA, Central, South), Europe, LATAM, Middle East, Asia, MENA, APAC
- eCTD, NeeS, Paper and Electronic Paper Formats

Regulatory Document Compliance
- Manage Quality Documentation supporting the Document Compliance specification
- 8 years of experience in Acrobat Pro and document compliance tool such as ISI Toolbox, PitStop Pro and others

BSC Degree “Chemistry and Quality” – Faculty Aix-Marseille – 1998

Diploma of Higher Education “Chemistry and Environment” – IUT Montpellier – 1997

 

Franck has extensive experience in Regulatory Registration Dossiers gained through a position in the Electronic Document Management Department during the past 8 years. He has expertise in a wide range of Publishing types of dossiers and corresponding formats

 

Prior to joining BlueReg Europe, Franck was Publishing and Document Compliance Expert (2000-2008) in the EDM Unit of Galderma R&D Company. In this role he was responsible of Publishing for Regulatory registration dossiers, the externalisation of activities, the planning for Publishing activities and the Regulatory Document Compliance.

These experiences enabled him to extend and strengthen his skills in Submission dossiers (European CP, DCP, MRP and National Procedures, US NDA/IND/IDE/PMA, CA NDS, ACTD, etc…) in required (eCTD, NeeS, and Paper) Formats, in Publishing Project Management and in Regulatory Document Compliance

 

In May 2018, Franck moved to consultancy and joined BLUE‐REG EUROPE.

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