Head of Regulatory Affairs

vor 4 Monaten

Frankfurt Am Main, Deutschland Viatris Vollzeit

Mylan Germany 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.

Every day, we rise to the challenge to make a difference. As Head of Regulatory Affairs Germany you will be responsible for ensuring strong commitment to regulatory compliance according to the German national drug law to maintain national licenses, to support continuous supply for marketed products and timely launch of Viatris’ product portfolio.

Key responsibilities for this role include:

- Lead the Regulatory Team to ensure agreed objectives are met and responsibilities are fulfilled; develop talents and offer a culture of learning & collaboration
- Performs to achieve local commercial targets and supports the cross-functional local organization as well as regional initiatives including budget monitoring, regulatory compliance reporting and measuring regulatory KPI's.
- Drive Regulatory Team to meet global and regional standards and meet agreed timelines (e.g. timely safety submission, high quality translations, artwork RTF, pharmaceutical documentation compliance).
- Manage external service providers setting clear objectives, frameworks, and responsibilities
- Counsel peers and other affiliates’ staff in any regulatory related questions or projects
- Manage projects related to regulatory affairs in collaboration with regional regulatory functions or country specific commercial functions in a timely and cost-effective manner.
- Perform regulatory launch management with focus on generic molecules, in strong collaboration with supply, quality, marketing and medical functions to ensure timely and successful marketing of the product.
- Collaborate with regional regulatory and commercial leaders for local market specific strategic requirements to ensure that national drug law and health authority guidelines are met.
- Oversee & Perform artwork approval as information officer (-74a AMG) for products marketed by all German entities

The minimum qualifications for this role are:

- Doctorade or Master’s degree in Natural science or pharmaceutical related/equivalent area
- Track record in Regulatory Affairs Management in the pharmaceutical industry in an affiliate in Germany and profound knowledge of the German Drug law (minimum 10 years)
- 10 Years experience in Leadership of large teams in an international pharmaceutical enterprise
- Project Management capabilities (i.e. Launch of generic drugs, Name changes, rebranding or comparable)
- Fluent German and English skills are a must

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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