Labelling Hub Manager (regulatory)

Viatris

Regulatory activities pertaining to labelling updates
Subject matter expert support
Local labelling text preparation
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

Job Summary

  • 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.
  • Ensure local labelling text is prepared right first time and on-time according to agreed company procedures and objectives.
  • 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.

Matching Summary

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.

Skills & Requirements

Must-have

  • regulatory activities pertaining to labelling updates
  • Subject Matter Expert support
  • local labelling text preparation
  • health authority questions
  • Core Data Sheet or other Reference Label
  • Regulatory Information Management System
  • Trackwise Change control environment

Nice-to-have

  • innovative approaches/recommendations
  • collaborative culture
  • courage and resilience
  • truly diverse, inclusive and authentic workplace

Key Requirements

  • Bachelor’s degree in science, Medicine or Pharmacy
  • Labelling and Regulatory experience
  • Regulatory experience working with Regional Health Authorities
  • in-depth Regional Labelling knowledge
  • advanced local language capability
  • Understand GLC requirements/ processes and EU/ US regulatory requirements

Work Rights

Not specified

Tailored Resume

Cover Letter