Job Description

1658 Viatris Pharmaceuticals S.A.S.

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 and here's how the Labelling Hub Manager role will make an impact:

The Labelling Hub manager is responsible for regulatory activities pertaining to labelling updates for determined country/ies according to internal procedure and legislation applied to country/ies under her/his responsibility. Provide Subject Matter Expert support to the Global Labelling Hub and Global Compliance Director, and other Stakeholders, with initiatives which impact, or may impact, labelling activities within the determined region and country/ies.

Key responsibilities for this role include: Point of Contact to Global Labelling Team regarding countries/licenses under her/his responsibility. Reports on agreed key performance indicators for set region. Onboards and manages regional assigned labelling associates. Communicate clearly issues and resolutions to peers and subordinates in a meaningful way. Ensure local labelling text is prepared right first time and on-time according to agreed company procedures and objectives. Support regional labelling team members with health authority questions, requests for further information, preparation, and review of labelling documents prior to submission. Advise Global Labelling Hub and Global Compliance Director regarding any deficiencies or issues. Ensure that supportive documents, not limited to Core Data Sheet or other. Reference Label such as USPI, SmPC are obtained in a timely manner to the countries according to local legislation. Arranges and updates Local Labelling texts above market on behalf of all impacted markets to ensure their conformity with internal procedures and local legislation. Manage all labelling variations through the Regulatory Information Management System and Trackwise Change control environment as needed to show compliance to global submission timelines and valid reason for delay. Liaise with Translation vendors as needed. General knowledge of preparing artwork from labelling text and the interface with Launch Management, Supply Chain and Quality teams. Ensures maintenance of relevant systems according to relevant SOPs. Ensures compliance with all relevant company SOPs. Provide support during Medical and Regulatory Audits.

The minimum qualifications for this role are: Bachelor's degree in Science, Medicine or Pharmacy, or another related field Labelling and Regulatory experience Regulatory experience working with Regional Heath Authorities and in-depth Regional Labelling knowledge Highly developed interpersonal, presentation and communication skills with advanced local language and English language capability

If you have the following characteristics, it would be a plus: Master's Degree, PharmD, or PhD in Science, Medicine, or Pharmacy Ability to provide innovative approaches/recommendations to product labelling that meet corporate goals while maintaining compliance with relevant laws and regulations Understand GLC requirements/ processes and EU/ US regulatory requirements The ability to influence effectively in a matrixed, cross functional team environment

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.

R5633553