Hiring: Sr Director, Regulatory Affairs Company: Rezolute, Inc. Location: Redwood City, CA Job Posted Time: 2026-09-11 11:48:20 Target Skills & Keywords : Agile, Risk Management About the job Experience: •15+ years of regulatory affairs experience in the biopharmaceutical industry. Required Skills: •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. Qualifications: •BS/MS degree required; advanced degree desirable •Significant experience with biologics development, including contribution to successful BLA submissions and approvals. •Demonstrated technical knowledge associated with successful submissions to regulatory agencies •Knowledge of Clinical, Nonclinical and CMC regulatory issues, quality systems and processes. •Knowledge of and success with regulatory designations (e.g. orphan, Fast-track. Breakthrough Therapy Designation) and ex-US equivalents. •Strong experience in rare disease drug development, including endocrinology, metabolic disorders, and/or oncology. •Demonstrated success in health authority interactions. •Comprehensive expertise in CMC requirements for biologics, including manufacturing, comparability and lifecycle management. •Solid functional working knowledge of global regulatory requirements (EMA, PMDA) is a plus. •Proven ability to operate effectively in small to mid-sized biotech environments in a hands-on capacity. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!