Simone Busson

Simone Busson

Publishing Manager

Key Knowledge Areas:

  • Publishing of Regulatory Dossiers (new registrations, pre- and post-marketing activities, geographical roll-out)
  • InSight Publisher (PAREXEL) / eCTD Manager (EXTEDO)
  • eCTD/Nees/paper formats
  • Document formatting / compliance
  • Geographical regions: EU/US/CA/CH/LATAM/Middle East
  • Submission portals (eGateway, PSUR repository, CESP)
  • Project Management Activities

Contact

Education

  • Certificate “Pratique de Français Commercial et Economique” ‐ Chamber of Commerce and Industry, Paris
  • Certificate of English for Commerce Second Level ‐ Chamber of Commerce and Industry, London
  • Foreign Language Secretary Diploma (English & French) ‐ Merkur Akademie International (Germany)

About Simone

 

Simone has extensive experience in Regulatory Affairs gained over the past 20 years.

 

Simone is a publishing manager and has been involved in various regulatory projects assisting start-up to international companies.

Background/Previous experience

Before joining Blue Reg, Simone worked as a Publishing Associate at Galderma R&D (2012 -2018) in Sophia-Antipolis (France), where she was in charge of the publishing of regulatory dossiers with InSight Publisher for Europe, US, and Export countries as well as the publishing of Clinical and Non-Clinical Reports. She was responsible for the annual planning of publishing activities with prioritization of projects for the publishing team, process definition and writing of work instructions for publishing activities, and training of the regulatory affairs team on eCTD requirements, submission portals, and Documentum.

 

In 2009 Simone moved to consultancy where she was in charge of European eCTD and NeeS publishing according to ICH eCTD specification and NeeS guideline as well as advising clients about European submission and publishing requirements.

 

Prior to that Simone worked as Regulatory Affairs Assistant at Allergan R&D (2000 – 2009) and was in charge of the compilation of documents and the handling of the administrative part of several regulatory procedures in Europe (MRP/DCP/CP and National Applications).

 

Simone joined BlueReg in January 2019 as Publishing Manager. She acts as project manager for publishing projects and ensures high quality and on time delivery of consulting services to clients for publishing and document formatting activities.