Are you looking for a highly visible regulatory leadership role where you can bring a more strategic focus along with your your scientific and regulatory expertise in all phases of product development? If so, this Regulatory Affairs Management Director position could be an exciting opportunity to explore. This role is to drive the US regulatory strategy of a portfolio of assets (in development and lifecycle), to serve as the Agency contact, as well as represent regulatory affairs within cross-function internal teams. There is a focus on clinical/ labelling aspects, as well as input into CMC strategy, preparation for authority consultations, full IND/BLA submissions, post approval variations, coordinating submissions, providing input and authoring some of the
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