Regulatory Affairs Documentation Specialist (m/f)

Job type:
12 MM+
Hays AG
Basel region
flag_no Switzerland

Project description:
This project is archived and not active any more.
You will find vacant projects in our project database.

We are looking for a
Regulatory Affairs Documentation Specialist (m/f)

Reference: en
Start: 11/17
Duration: 12 MM+
Place: in Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen

Your tasks:
  • Ensure technical documentation support by preparation and formatting of scientific documents;
  • Maintenance of documents in the document management system; compilation of submission Dossiers, hand-over to publishing team
  • Prepare and update technical regulatory documents according to instructions and ensure adherence to applicable regulatory (e.g. CTD) and the clients documentation standards
  • Apply document formats using customized Word templates and format detailed data tables and figures
  • Import and maintain documents in document management systems (e.g. Documentum) or document-sharing systems (e.g. SharePoint)
  • Collaborate with regulatory product managers and with internal partners

Your qualifications
  • Good scientific background (e.g. minimum education as laboratory assistant or BA/BS (or equivalent) in chemistry, biology or pharmacy)
  • Excellent command of Word, Excel and Acrobat and experience with document management systems (e.g. Documentum) and document sharing systems (e.g. SharePoint)
  • Attention to detail and consistency, especially with respect to style, format, and layout and ability to format technical regulatory documents using electronic tools
  • Previous experience with regulatory documents and dossier structures (e.g. CTD) or in the biotech or pharmaceutical industry is beneficial

- Regulatory affairs assistant