Labeling Hub Manager

Mylan, Lda.

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

This posting supports ongoing hiring needs and may be used to consider candidates for upcoming opportunities.

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on a number of award lists that demonstrate the impact we are making.

Every day, we rise to the challenge to make a difference, and here’s how the Labeling Hub Manager role will make an impact:

By ensuring compliant and timely implementation of labeling updates across assigned countries and serving as a trusted subject matter expert to support regional and global stakeholders on labeling-related initiatives.

• Key Point of Contact to Global Labelling Team regarding countries/licenses under her/his responsibility
• 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 her Labelling Hub Manager 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 English language capability

• 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 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 https://www.viatris.com/en/Careers/Diversity-and-Inclusion

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 https://www.viatris.com/en/about-us/corporate-responsibility

A t Viatris, we offer competitive salar ies , 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.