Labelling Hub Manager (Regulatory)

Responsibilities

• Manage regulatory activities pertaining to labelling updates for assigned countries in accordance with internal procedures and local legislation
• Act as the primary point of contact for the Global Labelling Team regarding specific countries and licenses
• Onboard and manage regional assigned labelling associates
• Ensure local labelling text is prepared accurately and on time according to company objectives
• Support regional team members with health authority questions, requests for information, and the review of labelling documents prior to submission
• Manage all labelling variations through the Regulatory Information Management System and Trackwise Change control environment
• Liaise with translation vendors and coordinate with Launch Management, Supply Chain, and Quality teams regarding artwork preparation
• Report on agreed key performance indicators for the assigned region

Requirements

• Bachelor's degree in Science, Medicine, Pharmacy, or a related field
• Proven experience in Labelling and Regulatory affairs
• Experience working with Regional Health Authorities and in-depth regional labelling knowledge
• Advanced local language capability and highly developed communication skills
• Understanding of EU and US regulatory requirements
• Ability to influence effectively within a matrixed, cross-functional team environment

Benefits

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

About the Company

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands. With a mission to empower people worldwide to live healthier at every stage of life, we provide access to high-quality medicines to approximately 1 billion patients annually.