Beschreibung
We are looking for a
Dossier Update Consultant (m/f)
Reference: -en
Start: 01/17
Duration: 6 MM
Place: in Hamburg
Branch: Wettbewerber
Your tasks:
- Submission of chemistry, manufacturing and controls (CMC) elements of biologicals (allergen products)
- Preparation, review and assembling of relevant documents with regard to dossier maintenance
- Preparation of CMC regulatory filings to health authorities (mainly europe)
- Evaluation of change requests in the change control process
Your qualifications
- Experience in Regulatory Affairs business
- Excellent knowledge of regulatory CMC (Module 3, 2.3)
- Experience with document management tools
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager