Job Description
About the Role
As a Labelling Strategy Regulatory Affairs Consultant you will act as a labeling strategist within Global Regulatory Affairs (GRA). You will drive the maintenance of the Company Core Data Sheet (CCDS), the US Prescribing Information (USPI) and the EU Summary of Product Characteristics (SmPC) for product portfolio, as assigned, to ensure optimal alignment of the company position, labeling requirements, and commercial opportunities for a therapeutic area. You will ensure that the company core product claims across products with the same active substance are globally aligned and lead the Global Labeling Committee assessment of proposed changes to the CCDS, including management of the exception process between the CCDS and the USPI and EU SmPC.
The role can be home or office based in various European locations.
Key Responsibilities
- Maintains the Company Core Data Sheet, the USPI and the EU SmPC as assigned.
- For the CC...