Regulatory Affairs Labelling Manager
CK Group are recruiting for a Regulatory Affairs Labelling Manager to join a bio-pharmaceutical company working remotely on an initial 6-month contract basis. Role outside of IR35
Company: This company is one of the world's largest biotech companies which is a leading provider of both cancer treatments and in vitro diagnostics.
The Role: The main purpose of the role will be to
- Drive and optimise the strategy for the creation and maintenance of Core Data Sheet
- Author and maintain CDS, as well as manages the CDS processes
- Provide regulatory strategic recommendations concerning acceptable labelling in regional markets, in collaboration with the relevant functions
Further responsibilities will include:
- Guiding and supporting the implementation of CDS into the Local Product Labels and manages local label deviations
- Leading/contributing to company responses on HA questions pertaining to EU and US labelling
- Giving specific guidance on labelling regulatory issues such as legislation, guidelines, procedures to the RAFT and Project teams. Your Background: To succeed in this role, you will come from a Life Science background with considerable experience in Strategic Regulatory Labelling
For more informationor to apply for this position, please contact Hendre Moolman on 01438 842 970 or email firstname.lastname@example.org.