Labelling Hub Manager (Regulatory)

The Role & What You Will Be Doing

The Labelling Hub Manager is responsible for regulatory activities pertaining to labelling updates for determined countries in accordance with internal procedures and local legislation. They provide subject matter expertise to the Global Labelling Hub and Global Compliance Director, and support initiatives that may impact labelling activities within the region.

• Point of Contact to the Global Labelling Team regarding countries/licenses under their responsibility.
• Report on agreed key performance indicators for the set region.
• Onboard and manage regional 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 the Global Labelling Hub and Global Compliance Director regarding any deficiencies or issues.
• Ensure supportive documents, not limited to Core Data Sheet or other reference labels such as USPI, SmPC, are obtained in a timely manner to the countries in accordance with local legislation.
• Arrange and update local labelling texts above market on behalf of all impacted markets to ensure 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.
• Have general knowledge of preparing artwork from labelling text and the interface with Launch Management, Supply Chain and Quality teams.
• Ensure maintenance of relevant systems according to relevant SOPs.

About Your Skills & Experience

• Bachelor's degree in Science, Medicine, Pharmacy, or another related field.
• Advanced 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.
• Capability to provide innovative approaches/recommendations to product labelling that meet corporate goals while maintaining compliance with relevant laws and regulations.
• Understanding of GLC requirements/processes and EU/US regulatory requirements.
• Ability to influence effectively in a matrixed, cross functional team environment.

Benefits

• Excellent career progression opportunities
• Work life balance initiatives
• Bonus scheme
• Health insurance
• Pension

Equal Opportunity Employer

Viatris is an Equal Opportunity Employer.