Senior Labeling Hub Manager

About the role

Viatris, a global healthcare company supplying medicines to about 1 billion patients each year, is hiring a Senior Labeling Hub Manager in Lisbon, Portugal. The role leads regional labelling teams supporting Pan European labelling of generic and branded products, from strategy and project planning through to artwork implementation, and supports the Global Labelling Operations Director.

Key responsibilities

• Develop labelling strategies, project plans and execute them in line with timelines for label creation and updates.
• Manage and lead regional labelling team members, set objectives, run mid-year and end-year reviews, and ensure training, development and coaching.
• Support the Global Labelling Operations Director and other stakeholders on initiatives affecting labelling in the European Economic Area.
• Ensure accurate, timely labelling updates and support team members with health authority queries and document review before submission.
• Advise the Core Labelling Operations Director on deficiencies and issues, and give regulatory strategy for new, pending and approved dossiers.
• Review Company Core Data Sheets and determine labelling updates, and liaise with legal on patent and exclusivity information.
• Prepare artwork from labelling text and coordinate with Launch Management, Supply Chain and Quality, ensuring compliance with end-to-end labelling to artwork implementation.
• Maintain up-to-date knowledge of regional laws and regulations, implement new requirements promptly, and take part in internal and external audits.

Required profile

• 5+ years of experience in product labelling and labeling development.
• 3+ years of leadership experience, including managing teams and leading cross-functional initiatives.
• 3+ years of regulatory affairs and/or project management experience with extensive labeling expertise.
• Experience in the pharmaceutical, biotechnology or healthcare industry.
• Ability to influence stakeholders across functions and to develop compliant labeling solutions.

Required skills

• Electronic submission systems such as Lorenz or equivalent.
• Change control systems such as TrackWise or equivalent.
• Document control and document management systems.
• Knowledge of global and cross-functional environments.