Description
We are looking for a
Submission Manager (m/f)
Reference: -en
Start: asap
Duration: 6 MM+
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Editing technical documents with regard to clarity, grammar, spelling and punctuation according to regulatory guidelines
- Coordination of regulatory documents
- Generating submission timelines, track submission activities, provide status updates
- Provide input for system enhancements, process updates and for submission model documents
Your qualifications
- Bachelor degree in English, Biology, Chemistry, Pharmacy or related
- Profound editing experience in a scientific or technical field (eCTD, FDA, EMA guidelines)
- Excellent communication skills in English (written/verbal)
- Expert-level proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat and document management systems/document sharing systems
- Good organisational and time management skills
Skills:
- Regulatory affairs assistant
Keywords: Regulatory Affairs Assistent