Description
We are looking for a
Regulatory Affairs Manager CMC (m/f)
Reference: -en
Start: asap
Duration: 3 MM+
Place: in Hesse
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Regulatory and technical CMC compliance (global markets)
- Maintenance and global defence of pharma product licenses
- Coordination of CMC maintenance activities (with Manufacturing Division)
- Global product development
- Regulatory CMC documentation
- Development of regulatory CMC strategies
- Analysis of new regulatory CMC requirements
- Contacts to regulatory authorities (BfArM and FDA)
Your qualifications
- University degree in pharmacy (or Life Science)
- Experienced in Regulatory Affairs (CMC)
- Experienced in leading an international team
- Understanding of animal health product research, development processes, project management
- Ability to work with international teams
- English fluent
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager