Description
We are looking for a
CMC Dossier Update Specialist (m/f)
Reference: -en
Start: 09/16
Duration: 18 MM+
Place: in Schleswig-Holstein
Branch: Wettbewerber
Your tasks:
- Develop global regulatory strategies for submission of Chemistry, Manufacturing and Controls (CMC) elements of biologicals (allergen products)
- Provide regulatory guidance to project and product teams
- Work closely with authors of dossier sections and prepare/review and approve CMC regulatory filings to health authorities (mainly Europe)
- Evaluate change requests in the change control process
Your qualifications
- Regulatory CMC experience (module 3, 2.3)
- Experience with document management tools
- Business fluency in English
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager