Regulatory Affairs Manager CMC (m/f)

Job type:
on-site
Start:
asap
Duration:
24 MM
From:
Hays AG
Place:
Hesse
Date:
04/12/2016
Country:
flag_no Germany

Project description:
Warning
This project is archived and not active any more.
You will find vacant projects in our project database.

We are looking for a
Regulatory Affairs Manager CMC (m/f)

Reference: 302244/1-en
Start: asap
Duration: 24 MM
Place: in Hesse
Branch: Wettbewerber

Your tasks:
  • CMC and Regulatory Compliance life cycle management
  • Compilation of CTD sections for module 3 and Quality Overall Summaries according to current global regulatory expectations
  • Tracking and follow-up of regulatory information


Your qualifications
  • Enhanced knowledge regarding European and US regulatory requirements (CMC); other regions (e.g. Emerging markets) beneficial
  • Talent and special interests in compliance work
  • Fluent language skills in English and German



Skills:
- Regulatory affairs manager