Regulatory Affairs Manager

vor 2 Wochen

Wien, Österreich Viatris Vollzeit

7083 Mylan Österreich GmbH

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via

Access - Providing high quality trusted medicines regardless of geography or circumstance;

Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and

Partnership - Leveraging our collective expertise to connect people to products and services.

Key responsibilities for this role include

  • Timely submissions and execution of the projects
  • Staying updated with Austrian regulatory requirements and processes and the authority organization
  • lnteracting with various stakeholders on a local and regional level (Global Regulatory Affairs, Global Labelling etc.) and the Regulatory Authority
  • Monitoring regulatory trends and provides strategic input to the management
  • Adhering to local processes and procedures to ensure clear regulatory responsibilities within the affiliate in line with Global SOPs and local regulations
  • Supporting both internal regulatory audits and Regulatory Authority inspections, and ensures that any corrective actions are completed according to schedule

The minimum qualifications for this role are

  • Bachelor or Master’s Degree in natural or life sciences
  • 5 years of professional experience in Regulatory Affairs related to pharmaceutical products
  • Functional knowledge of pharmaceutical sciences
  • Knowledge of the Austrian national and EU regulations, regulatory guidance, policies, and procedures
  • Good planning and problem-solving skills, along with the ability to build and manage close relationships with all relevant stakeholders
  • Excellent communication skills in German and English (written and oral)

The gross annual salary is at least € 50.000.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.

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