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This position serves as a key role in the effective implementation of the global development strategy leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical development (including
Develop and execute robust global regulatory CMC strategies for marketed biological products throughout their lifecycle. Plan, review, and prepare CMC documentation for marketing authorization maintenance, post-approval variations, and health authority
It is expected that you will provide regulatory expertise and guidance on European/ROW procedural matters and documentation requirements to the Global Regulatory Team and Compound Development Team to ensure an optimal European/ROW regulatory strategy for