Associate Director, Regulatory Affairs
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About The Position
As the Associate Director of Regulatory Affairs, you will play a key role in managing and overseeing regulatory affairs activities within our organization. You will be responsible for planning and executing regulatory strategies that enable Spyre to initiate and manage clinical trials. You will also contribute to preclinical, CMC, and clinical development plans with the goal of ensuring Spyre performs the necessary studies to gain and maintain product approval(s) that are consistent with our target product profile(s). You will act as the overall lead of global regulatory applications for at least one and possibly multiple drug candidates and will lead the submission of original investigational new drug and clinical trial applications. You will also support the team by contributing to the development of other assets for which you are not the overall lead, and by contributing to the development of processes for the Regulatory Department.
