Senior Manager, Regulatory Affairs CMC

Job description

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. Role Summary: As the Senior Manager, Regulatory Affairs CMC), you will operate as the Regulatory CMC lead for multiple programs, owning strategy and execution from early development through clinical milestones. This is a high-impact, high-ownership role for someone who thrives in a fast-moving biotech environment. You will be expected to lead from the front—writing, project-managing, problem-solving, and delivering—not just coordinating. This role requires technical CMC expertise, strong communication skills, and the ability to manage multiple priorities. Key Responsibilities: - Act as the Reg CMC lead for assigned programs, driving strategy, execution, and timelines. - Personally author sections of Module 2 and 3 (QOS, drug substance, drug product, comparability, stability, etc.). - Own CMC regulatory deliverables end-to-end with minimal oversight. - Lead and deliv...