Description
We are looking for a
Regulatory Affairs Manager - Operations (m/f)
Referenz: -en
Beginn: asap
Dauer: 6 MM++
Ort: Belgium and remote
Branche: Medizintechnik
Ihre Aufgaben:
- Support in Regulatory Affairs Operations
- Understanding of EU RA Submissions in eCTD / CTD / NeeS /Papier
- Handling of Publishing Tools: ISI Suite – eCTD Express, ISI Publisher, ISI Writer
- Requirment for on-site work in Belgium
Ihre Qualifikation
- Document Management skills – FirstDoc /Documentum
- Understanding the principles of EU RA Submission Procedures
- Experience with ISI (Image Solution Software)
- English must
Skills:
- Regulatory affairs manager
Keywords: Publishing Regulatory Affairs Manager RAM elektronische Einreichung submission pharmazeutische Industrie Arzneimittel