Intercept Pharmaceuticals Inc.
Senior Manager, Regulatory Labeling (Finance)
POSITION SUMMARY:
The Senior Manager, Regulatory Labeling will partner with the Head of Regulatory Labeling and Promotion at Intercept and be responsible for supporting the content development, review, and internal approval of the proposed labeling (Company Core Data Sheet (CCDS), US Prescribing Information (USPI), and EU Prescribing Information (Pl).
This position will also support the work related to labeling negotiation with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) during review of the NDA/MAA and the labeling-related activities.
CORE ACCOUNTABILITIES:
The successful candidate must be able to perform each of the following satisfactorily:
Experience and Skills
QUALIFICATIONS: