Switzerland Regulatory Affairs Leader Opportunity
Vor 3 Tagen
We are seeking a seasoned Regulatory Affairs expert to lead our team in Switzerland. As a key member of the Viatris organization, you will play a critical role in ensuring compliance with Swiss regulations and fostering strong relationships with local health authorities.
About the Role:
- 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.
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