ViatrisLabelling Hub Manager (Regulatory)
McDermott Laboratories Limited
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
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.
Every day, we rise to the challenge to make a difference and here’s how the Labelling Hub Manager role will make an impact:
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 with global submission timelines and a 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.
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:
Bachelor’s degree in science, Medicine or Pharmacy, or another related field. Advance degree is a plus (
Labelling and Regulatory experience
Regulatory experience working with Regional Health Authorities and in-depth Regional Labelling knowledge
Highly developed interpersonal, presentation and communication skills with advanced local 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.
Benefits at 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. Some of our benefits include the following on top of a competitive salary:
Excellent career progression opportunities
Work-life balance initiatives
Bonus scheme
Health insurance
Pension
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
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.