Senior Manager, 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, and IL-23, and IL-17A/F as well as rational combination programs. As Senior Manager, Regulatory Affairs, you will play a key role in supporting regulatory planning and execution, initially focused on Spyre’s global Phase 3 clinical program, with the opportunity to contribute across the organization. Reporting to the Associate Director, Regulatory Affairs, this hands-on role will support study development, global study start-up, and clinical trial application lifecycle management. You will work closely with regulatory leadership and cross-functional project teams to establish regulatory plans, applications, processes, and define priorities. You will independently manage assigned deliverables, including submission planning and execution, document preparation and review and CRO oversight, while progressively assuming day-to-day regulatory leadership for designated studies within the overall program direction and regulatory strategy led by the Associate Director. You will identify regulatory risks and align regulatory activities across Clinical Development, Clinical Operations, Biometrics, Medical Writing, Safety, CMC, Nonclinical, and Quality. You will also provide practical regulatory input to study documents and support health authority interactions and responses. This role requires strong communication and collaboration skills to resolve complex regulatory issues, align project teams, and adapt quickly to drive work forward in a fast-moving, dynamic environment. Key Responsibilities: Regulatory Strategy and Planning: Support the development and implementation of regulatory strategies for assigned studies. Create a