Contact: Cornelia Walch, Staffing Manager
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
Our salary packages are competitive and take individual qualifications and experience into consideration. Moreover we offer attractive fringe benefits (e.g. profit sharing for all employees, modern company pension, childcare facility, training possibilities and global career opportunities). In accordance with the Austrian collective labour agreement, we advise you that the minimum gross annual salary for this role is 48,020.56 euros.
Sandoz is an equal opportunity employer