Director of Regulatory Affairs – Switzerland

Vor 4 Tagen

Zug, Schweiz TN Switzerland Vollzeit

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Director of Regulatory Affairs – Switzerland (m/f/d), Zug

Client: Viatris

Location: Zug

Job Category: Other

Job Reference: e4615d4f68eb

Job Views: 9

Posted: 21.01.2025

Expiry Date: 07.03.2025

Job Description:

Viatris Pharma 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;
  • Partnership – Leveraging our collective expertise to connect people to products and services.

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

Every day, we rise to the challenge to make a difference and here’s how the Director of Regulatory Affairs – Switzerland (m/f/d) role will make an impact:

  • Lead the Swiss Regulatory Team by delivering against or bettering expectations from regulatory stakeholders and ensuring close alignment with relevant Commercial Teams.
  • Drive the Swiss RA Team to meet global and regional standards and meet agreed timelines (e.g. timely safety variation submissions; high quality of the submissions, including label translations; timely update of artworks). Ensure that Viatris regulatory systems and databases are actively maintained by the RA team in line with company SOPs and Work Instructions.
  • Manage and influence interactions with local Health Authorities and build lasting, trusting relationships with Swissmedic ensuring the company requirements are delivered. Represent Viatris at National Trade Associations as and when applicable.
  • Stay informed and up to date on all local, regional or international legislative, regulatory or guideline changes that may impact our business sustainability. Provide appropriate direction, guidance and advice to ensure the correct interpretation and actions are taken in relation to these changes and their impacts on Viatris products (pharmaceuticals, medical devices, food supplements and cosmetics).
  • Ensure timely submission and approval of new MAs by managing the responsible and accountable regulatory personnel; ensure pre- & post-approval commitments including Risk Minimization Measures are communicated to the relevant company functions.
  • Provide direction to the Strategic Planning Process and join relevant projects and working groups (internal and external) to provide Regulatory advice and expertise which supports the delivery of company targets. Enhance the brand of Viatris. Provide appropriate regulatory guidance and support to the other company functions and stakeholders to meet business objectives.
  • Collaborate with Global and Regional RA on the regulatory strategies and preparation of the Marketing Authorization Applications by ensuring Swiss specific requirements are taken into account.
  • Assist Global and Regional RA teams for Scientific Advice meetings with Swissmedic; attend and participate in Health Authority inspections and meetings.
  • Take care of the local RA budget preparation and monitoring according to the indications and timelines provided by Regional RA.
  • Support regional initiatives in close cooperation with the Regional and Global RA teams: these may include improvement initiatives, regulatory compliance reporting and measuring regulatory KPI's.
  • Develop a vision for the RA Team in Switzerland in terms of how they best contribute to and improve delivery towards local market expectations, regional and global requirements.
  • Set performance expectations with all team members to ensure they maximize their abilities, have clear expectations set for them and complete regular honest conversations with team members to sustain performance levels. Fulfil the requirements of the Viatris Performance Management Process on time and to the highest possible standard.
  • Develops and agrees development plans with all team members to ensure incremental improvement year on year and that each team member has a career path.
  • Provide access to training and information material needed to upskill, retrain and grow as and when required.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

  • The ideal candidate will hold a master’s degree in a scientific related discipline.
  • Extensive experience in regulatory affairs (8+ years) and 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.
  • Experience of managing a team and leading a department is essential.
  • Experience of working cross-functionally with other company functions.
  • Proven track with Swissmedic interactions including but not limited to Scientific Advice Meetings.
  • Fluent German and English is required for this role.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

Why Viatris?

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. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit our website.

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit our website.

Viatris is an Equal Opportunity Employer.

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