Director of Regulatory Affairs

Vor 3 Tagen


Oberwil b Zug, Zug, Schweiz Viatris Vollzeit
About the Role

We are seeking a highly skilled and experienced Director of Regulatory Affairs to lead our Swiss Regulatory Team. As a key member of our organization, you will be responsible for delivering against or bettering expectations from regulatory stakeholders and ensuring close alignment with relevant Commercial Teams.

Key Responsibilities
  • Lead the Swiss Regulatory Team by driving global and regional standards and meeting agreed timelines.
  • Manage and influence interactions with local Health Authorities and build lasting, trusting relationships with Swissmedic.
  • Stay informed and up to date on all local, regional or international legislative, regulatory or guideline changes that may impact our business sustainability.
  • Provide direction to the Strategic Planning Process and join relevant projects and working groups (internal and external) to provide Regulatory advice and expertise.
  • Collaborate with Global and Regional RA on the regulatory strategies and preparation of the Marketing Authorization Applications.
Requirements

We are looking for a candidate with a master's degree in a scientific related discipline and extensive experience in regulatory affairs (8+ years). You should have deep knowledge of Swiss national regulations and regulatory guidance, policies and procedures, as well as knowledge of EU regulation.

Broad functional knowledge of pharmaceutical sciences and pharmaceutical industry is essential. Experience of managing a team and leading a department is also required. Fluency in German and English is necessary for this role.

About Viatris

Viatris is a global healthcare company that empowers people worldwide to live healthier at every stage of life. 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.

We are dedicated to building a truly diverse, inclusive and authentic workplace. If you're excited about this role but your past experience doesn't fully align with every requirement, we still encourage you to apply.



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