Sr Director, Regulatory Affairs

Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity.

Rezolute’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI). As Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders.

Position Summary

Reporting to the Chief Regulatory Officer, the Sr Director of Regulatory Affairs will join the regulatory team providing strategic and operational leadership supporting late-stage clinical development through regulatory submission, approval, and product launch. This individual will serve as a key member of the project team and provide regulatory support for strategy implementation across the functions with a primary focus on FDA interactions and U.S. registration.

The ideal candidate brings deep expertise in rare disease regulatory pathways and biologics development, including experience in endocrinology, metabolic, and oncology programs. This leader will have a strong understanding of CMC considerations for biologics and experience navigating complex regulatory requirements associated with BLA submissions.  The candidate will have experience in late-stage approval activities and support for commercial launch. 

This is a hands-on leadership role requiring both strategic vision and execution in a lean, fast-paced environment.