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 para neoplastic 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.

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.

• Develop and execute regulatory strategies for biologic programs in rare disease indications, including endocrinology, metabolic, and oncology consistent with corporate and project objectives and gain consensus across the organization with respect to those strategies.
• Key contributor in agency regulatory interactions, including the preparation of clinical stage (IND, CTA) and marketing (BLA, MAA) applications, and formal meetings.
• Pursue expedited pathways (e.g., Orphan Drug Designation, Fast Track, Breakthrough Therapy, RMAT where applicable).
• Provide regulatory guidance across Clinical Development, CMC, Nonclinical, and Commercial functions.
• Represent regulatory in project team discussions and present issues and solutions accordingly.
• Identify issues proactively that will impact programs and provide strategies to address them and communicate to the project teams and Company management.
• Ensure alignment of regulatory strategy with clinical development plans, applying special considerations for small patient populations and innovative trial designs.
• Identify and mitigate regulatory risks, including those specific to biologics.
• Monitor for emerging trends in regulatory policies, regulations, and guidelines; provide analysis and applicability to Rezolute programs and activities.
• Support business development, due diligence, and investor communications with regulatory insights.
• Ensure compliance with applicable laws and regulations related to our product development and marketing activities.

• BS/MS degree required; advanced degree desirable
• 15+ years of regulatory affairs experience in the biopharmaceutical industry.
• Significant experience with…