Regulatory Requirements Lead - Global Regulatory Intelligence

Role Summary -

We are seeking experienced and meticulous CMC Lifecycle Experts to join our Regulatory Intelligence team. This pivotal role focuses on leveraging CMC regulatory affairs experience to maintain our comprehensive regulatory requirements database (GRR). This involves analyzing regulatory nuances and ensuring the accuracy of content in the database.

This position requires good understanding of CMC regulations, particularly in major markets such as the EU or US, and will apply prior hands-on regulatory affairs experience to enhance our regulatory intelligence capabilities, rather than performing direct regulatory submissions.

Strategic Database Development & Management:

Contribute to the development, population, and ongoing maintenance of the Global Regulatory Requirements (GRR) database.

Leverage prior regulatory affairs experience to input, verify, and regularly review data related to variation c...