Senior Manager, Global Labelling, Regulatory

Senior Manager, Global Labelling
Your new company
One of my clients is looking for an experienced Regulatory Affairs Labelling Professional to join the team on a 12-month contracting basis. This is a remote contract job outside IR35.
Your new role
The key role as Senior Labelling Manager is to develop and maintain core labelling documents and create EU and USPI, or provide support for any other local product information throughout the product life cycle in accordance with processes, and to provide labelling guidance to support product teams and senior management in defining labelling strategy.As Senior Labelling professional, you will influence labelling team decisions based on precedent labelling negotiations experience and get alignment on proposed CCDS wording. Present proposed CCDS and key differences with EU-USPI to the Executive Labelling Committee (ELC) with the support of the product team to obtain internal approval before submission of major labels.Review scientific data, write effectively and summarise in the appropriate detail for labelling content. Provide input for the production of high-quality documents supporting changes to Iabelling content.
What you\’ll need to succeed
It is essential that those Labelling professionals applying for this contract job have experience of developing the CCDS, EU and USPI.
What you\’ll get in return
Flexible working options available.
What you need to do now
If you\’re interested in this role, click \’apply now\’ to forward an up-to-date copy of your CV, or call us now.
If this job isn\’t quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.