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. 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.

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 lead ing role in their assigned programs, and will work with support and guidance from senior regulatory management as needed.

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.

and expectations, as a member of operational study teams.

preferred. Solid understanding of US and global regulations and guidelines (21 CFR, FDA, ICH, GCP, GMP, eCTD). Demonstrated ability to identify regulatory risks and support resolution strategies.

Strong organizational skills with the ability to manage multiple priorities and meet deadlines.

Key Responsibilities

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. ) to ensure alignment with regulatory obligations and relevant guidelines (ICH, FDA, EMA, ROW).

Qualifications

Bachelor’s degree from an accredited institution required. 5–8+ years of pharmaceutical/biotech R&D experience, including 3–5+ years in Regulatory Affairs (or equivalent combination of education and experience). Small-midsize biotech experience highly preferred.

Strong ability to interpret scientific data and understand regulatory implications for biologics. Direct experience supporting US regulatory submissions, including IND preparation or maintenance; experience with eCTD submissions required. Experience contributing to or coordinating health authority submissions and responses.