Director, Regulatory Affairs

Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F as well as rational combination programs. Role Summary: As the Director, Regulatory Affairs, you will play a key role in managing and overseeing regulatory affairs activities and execution within our organization, initially focused on Spyre’s IBD program. 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 one or more drug candidates and will lead the submission of original investigational new drug and clinical trial applications. You will lead efforts to plan and prepare for meetings with global health authorities (Type C & EOP2 meetings with FDA, EMA scientific advice, etc.) and support live discussions. You will also support the team by contributing to the development of other assets for which you are not the overall