About the Role
As a Labelling Strategy Regulatory Affairs Senior Consultant you will act as the principal labeling strategist within Global Regulatory Affairs (GRA). You will drive the development of Labeling strategies, the creation and maintenance of the development Company Core Data Sheet (dCCDS), 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. As a seasoned expert, provides strategic input into the GRA Therapeutic Area Team from a labeling perspective. You will ensure that the company core product claims across products with the same active substance are globally aligned and leads the Global Labeling Committee assessment of proposed changes to the dCCDS/CCDS, including management of the exception process between the CCDS and the USPI and EU SmPC.