Beschreibung
We are looking for a
Regulatory Affairs Coordinator (m/f)
Reference: -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