Atsena Therapeutics is a clinical-stage gene therapy company that is leveraging novel AAV vectors designed to overcome the unique hurdles presented by retinal disease to reverse or prevent blindness. Our lead program, ATSN-201, is a gene therapy for X-linked retinoschisis (XLRS), which is currently being evaluated in a Phase 1/2 clinical trial. We are also advancing ATSN-101, a gene therapy for the treatment of GUCY2D Leber congenital amaurosis (LCA1) towards a Phase 3 trial. We have additional preclinical programs to treat other forms of inherited retinal disease as well as novel capsid technology suitable for addressing large indications.
At Atsena, we are bringing patients into focus. We are passionate about finding cures for visually impaired and blind individuals and are driven by cutting edge science to ensure we achieve the safest and most effective results.
Position Summary:
The Regulatory Operations Manager will be responsible for overseeing the preparation, submission, and lifecycle management of regulatory filings to health authorities, including the FDA, EMA, and other international agencies. This role is crucial in ensuring timely, compliant, and high-quality regulatory submissions for our gene therapy programs across multiple jurisdictions.
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