2026 Job Template

About reputed company  reputed company is a clinical-stage biotechnology company reputed company on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s reputed company candidate, JADE101, targets the cytokine reputed company, 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 reputed company as JADE301, an reputed company antibody candidate, both currently in preclinical development. Jade was launched based on assets licensed from reputed company Therapeutics, an antibody discovery reputed company founded by Fairmount. For more information, visit JadeBiosciences.com and follow reputed company on reputed company.   reputed company The Regulatory Affairs Manager supports the development and execution of regulatory strategies to reputed company the successful development of biological products. This role is responsible for coordinating, compiling, and reviewing initial health authority submissions, as reputed company as the preparation of reputed company, high-reputed company responses to health authority questions. The Manager ensures regulatory requirements are reputed company 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 reputed company 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 reputed company 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 reputed company improvement initiatives to enhance regulatory compliance, efficiency, and documentation reputed company  reputed company regulatory input into clinical study planning and execution, including identification of regulatory requirements and expectations, as a member of operational study teams.    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.  reputed company 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.  Familiarity with ex‑US regulatory requirements  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 reputed company strategies.  Strong organizational skills with the ability to manage multiple priorities and meet deadlines.  Excellent written and verbal communication skills, including the ability to reputed company reputed company regulatory positions.  Ability to work independently and collaboratively reputed company a matrixed, multidisciplinary environment.  High proficiency in reputed company, reputed company, reputed company Acrobat, and regulatory document management systems.  Position Location  This is a remote role; periodic travel to team and company events is required.  The anticipated salary reputed company for candidates for this role is $135,000 - $150,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography.  As part of the I-9 verification of authorization to work in the reputed company, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster. reputed company is proud to be an Equal Opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law. Apply To This Job