Beschreibung
We are looking for a
Senior CMC Regulatory Manager (m/f)
Referenz: -en
Beginn: asap
Dauer: 6 MM++
Ort: in Basel region
Branche: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Ihre Aufgaben:
- Support different global CMC regulatory teams
- Write CMC sections of clinical (IND/CTA) and marketing applications (NDA/MAA)
- Interact with representatives from technical functions in order to assemble CMC documentation for global submissions
- Review submissions, collect information from CMC teams and reviewers
- Lead review discussions and modify documents
Ihre Qualifikation
- Life Sciences background
- Experience with CMC regulatory affairs, formulation development or analyitcal development
- Know-how of IND/CTA and NDA/MAA submissions
- Experience in Quality by Design
- Perfect English, written and spoken
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager regulatory affairs CMC IND CTA NDA MAA QbD life sciences