Manager, Regulatory Affairs

About Jade Biosciences  Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate, JADE101, targets the cytokine APRIL, and is currently being evaluated in a Phase 1 clinical trial for the treatment of immunoglobulin A nephropathy. Jade’s pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE301, an undisclosed antibody candidate, both currently in preclinical development. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more information, visit JadeBiosciences.com and follow the Company on LinkedIn. Role Overview The Regulatory Affairs Manager supports the development and execution of regulatory strategies to enable the successful development of biological products. This role is responsible for coordinating, compiling, and reviewing initial health authority submissions, as well as the preparation of timely, high-quality responses to health authority questions. The Manager ensures regulatory requirements are understood and incorporated into program activities while maintaining compliance with global regulations and internal standards. The Regulatory Manager will have recognition as a leading role in their assigned programs, and will work with support and guidance from senior regulatory management as needed.    Key Responsibilities  Drives timely submission of regulatory submissions including initial trial applications (e.g. IND, CTA) and marketing applications, and the documentation required to maintain these applications.  Draft, edit, and review regulatory documents such as meeting requests, query responses, and submission modules.  Conduct regulatory review of product documentation intended for submissions to ensure accuracy, consistency, and compliance with FDA and global regulations.  Participate in the review of key clinical and nonclinical documents (protocols, IBs, CSRs, DSURs, etc.) to ensure alignment with regulatory obligations and relevant guidelines (ICH, FDA, EMA, ROW).  Manage the processing, formatting, and operational aspects of regulatory submissions, ensuring compliance with regulatory requirements and internal quality standards.  Identify regulatory risks proactively and contribute to risk‑benefit assessments and mitigation strategies.  Maintain up‑to‑date knowledge of US and global regulations, guidance documents, and evolving regulatory expectations.  Monitor the external regulatory landscape and communicate potential impacts to internal stakeholders.  Support continuous improvement initiatives to enhance regulatory compliance, efficiency, and documentation quality  Provide regulatory input into clinical study planning and execution, includ...