Regulatory Affairs Labelling Manager

Regulatory Affairs Labelling Manager

Your newpany

This consultancy is looking to strengthen their Regulatory Labelling group by taking on an experienced Regulatory Affairs Labelling professional for a contract job. This job is outside IR35 and has scope for extension.

Your new role

As the Regulatory Affairs Labelling Manager, you would be responsible for developing the strategy and leading the development and update of core labelling documents and for overseeing implementation at a local and regional level.As the Labelling Manager, you will play a key role in leading the timely creation / management of regulatorypliant,petitive and up-to-date core labelling documents throughout the product lifecycle, including thepany Core Data Sheet (CDS), Global Patient Leaflet and Target Label Profiles.As the Regulatory Affairs Labelling Manager contract, you will oversee timely implementation of CDS updates with regional labels and monitorpliance with labelling processes and the preparation of supporting documents for core labelling changes, in collaboration with Medical Writing, ensuring alignment to the core labelling strategy and global regulatory strategy, as well as maintaining labellingpliance.

What you'll need to succeed

Experience of developing and implementing strategy for global labelling content, proven experience with document management and regulatory tracking systems, along with high-level labelling experience.

What you'll get in return

Remote working, outside IR35 rates