Regulatory Affairs Coordinator (m/f/d)


  • High school, PTA, CTA, MTA or similar education
  • Experience in pharmaceutical industry especially within regulatory affairs and ideally with some exposure to labelling
  • Excellent computer skills - MS Office applications (Word and Excel), eCTD / Document Management Systems
  • Support of Regulatory Managers and Specialists in all administrative well as operational tasks (incl. filing of documents to competent authorities, support in maintenance and keeping updated electronic databases)
  • Maintenance of the CH&EU product information (SmPC, PIL, labelling) folder Uploading of documents (approved SmPCs & PILs and any other relevant document) to Health Authorities portals (CH&EU)
  • Active communication with stakeholders for text updates for CH&EU following originator
  • Creation and maintenance of printed packaging material for EU
  • Manage general document translations
  • Germany: BfArM/PEI: publication of manufacturers in AMIS/PharmNet.Bund
  • Uploading of documents and dossiers into Document Management System (Docubridge)
  • Maintenance of Symfact database
  • Renewals in CH (as backup)
  • Organization of all country specific documents including translation and legalization (CPPs, CoAs, MLs, GMPs, Price Certificates, Letter of Authorizations, etc.) (as backup)
  • Maintenance and Updating of Artwork (all packaging materials) for CH (as backup)


» Job description


Employer:
Acino Pharma AG
Location:
8050 Zurich [CH]