Registration Manager (m/f)
Regulatory Affairs, Sandoz Development Center, Sandoz GmbH Kundl
Area of Responsibility
- Organisation and preparation of marketing authorisation documentation for new registrations, renewals, and variations according to the applicable guidelines, authority regulations and legal requirements
- Carries out regulatory activities independently and co-operates proactively with other departments
- Competent contact person, advising the Development Department, TechOps, QA and other internal and external stakeholders with regard to regulatory issues
- Coordination of registration strategies with the country-specific administrative marketing authorisation departments (RCCs)
- Regulatory evaluation of Change Requests
- Generation of regulatory guidance documents, review and approval of guidance documents, protocols, reports and SOPs where appropriate
- Representative of regulatory in the corresponding project team.
- Education: University degree (preferably PhD) in natural science such as pharmacy, chemistry, microbiology etc.
- Languages: fluent in German and English
- Experience: Minimum of 2 years of experience in the pharmaceutical industry