Description
We are looking for a
Regulatory Affairs Manager CMC (m/f)
Reference: -en
Start: 07/15
Duration: 18 MM
Place: in Hesse
Branch: Wettbewerber
Your tasks:
- Support Regulatory Affairs CMC
- Compilation of CTD sections for module 3 and Quality Overall Summaries following current global regulatory expectations
- Tracking and follow-up of regulatory information
- Life Cycle Management
Your qualifications
- Pharmacist/Chemist/Biologist
- Basic knowledge regarding European and US regulatory requirements (CMC), additional regions (e.g. emerging markets) preferable
- Talent and special interest in compliance work
- CMC expertise
- Business fluent German and English skills
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager