Description
We are looking for a
Regulatory Affairs Manager (CMC) (m/f)
Reference: -en
Start: asap
Duration: 18 MM
Place: in Hesse
Branch: Wettbewerber
Your tasks:
- Compilation of CTD sections for module 3 and Quality Overall Summaries following current global regulatory expectations
- Tracking and follow-up of regulatory information
- Provide support in Regulatory Affairs CMC
- Life Cycle Management
Your qualifications
- Pharmacist/Chemist/Biologist
- Basic knowledge of European and US regulatory requirements (CMC); know-how regarding other regions (e.g. Emerging Markets) beneficial
- Fluent German and English language skills
- Talent and special interests in compliance work
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager