Franck Vigliecca

Franck Vigliecca

Associate Director, Publishing

Key Knowledge Areas:

  • Publishing of Regulatory Registration Dossiers

IND, NDA, MAA (MRP/DCP/CP/NP), IDE, PMA, DSUR, ACTD Dossiers

Global regions : America (North US, CA, Central, South), Europe, LATAM, Middle East, Asia, MENA, APAC

eCTD, NeeS, Paper and Electronic Paper Formats

10 year’s experience in Publishing software tools

  • Regulatory Document Compliance

Manage Quality Documentation supporting Document Compliance specification

8 year’s experience in Acrobat Pro and document compliance tools

Contacter

Education

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

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

 

About Franck

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

Background/Past experience

Prior to joining BlueReg, Franck was a Publishing and Document Compliance Expert (2009-2018) in the EDM Unit of Galderma R&D Company. In this role he was responsible for Publishing for Regulatory registration dossiers, externalisation of activities, and 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 BlueReg.