Director of Regulatory Affairs
Vor 5 Tagen
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; and
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-
- 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
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