Labelling Hub Manager
4 weeks ago
**Position Summary and Objective**:
- 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.
**Minimum Requirements**:
Bachelor's Degree in Science, Medicine or Pharmacy, or another related field
Master's Degree, PharmD, or PhD in Science, Medicine, or Pharmacy will be advantageous
Labelling and Regulatory experience
Regulatory experience working with Regional Heath Authorities and in-depth Regional Labelling knowledge.
**Primary Responsibilities**:
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 to global submission timelines and valid reason for delay.
Liaise with Translation vendors as needed
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