Description
We are looking for a
CMC Regulatory Affairs Specialist (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Place: in Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- CMC Regulatory Affairs Specialist for small molecules
- Write CMC sections of post-approval marketing applications
- Write answers to deficiency letters
- Review of submitions within the team
Your qualifications
- University degree in chemistry, pharma or similar
- Deep knowledge of CMC RA, formulation development, quality and post-approval submissions
- Detail oriented
- Fluent in English
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager