Description
We are looking for a
Regulatory Affairs Documentation Specialist (m/f)
Reference: -en
Start: asap
Duration: 4 MM++
Place: in Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- 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)
- Collaborates with regulatory product managers and with internal partners
Your qualifications
- Good scientific background (e.g. minimum education as labor specialist 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)
- Tenacious 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
Skills:
- Regulatory affairs assistant
Keywords: Regulatory Affairs Assistent