Regulatory Affairs Coordinator (m/f)

Job type:
on-site
Start:
asap
Duration:
12 MM
From:
Hays AG
Place:
Hesse
Date:
09/24/2016
Country:
flag_no Germany

Project description:
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This project is archived and not active any more.
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We are looking for a
Regulatory Affairs Coordinator (m/f)

Reference: 317946/9-en
Start: asap
Duration: 12 MM
Place: in Hesse
Branch: Wettbewerber

Your tasks:
  • Under supervision, support regulatory submissions
  • Act as point of contact to answer any question and activities related to operational tasks for preparation, submission and archiving of dossiers
  • Ensure all technical aspects are covered to enable submissions to health authorities within agreed timelines
  • Conduct as requested regulatory activities such as dossier assembly, production and submission
  • Timely request of Registration samples where needed
  • All labelling activities including submission mock up and artwork preparation
  • Preparation of local documents for dossiers incl. translation of documents as needed
  • Maintain and update regulatory files, records and IT systems, databases used within GRA&QA (D2, RIMS, Eldorado, etc)


Your qualifications
  • Knowledge in Labeling and artwork preparation
  • Experience with preparing of local dossiers and translation of documents
  • Experince with D2, RIMS, Eldorado, etc
  • English business fluently



Skills:
- Regulatory affairs manager


Keywords: Regulatory Affairs Coordinator