Manager, Regulatory Affairs

🔥 0 minutes ago

🏄 California, Massachusetts, +1 more states – Remote

🏄 California – Remote 🍂 Massachusetts – Remote ☕ Washington – Remote

💵 $135k - $150k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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Jade Biosciences

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2024

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Jade Biosciences is a clinical-stage biotechnology company developing potentially best-in-class therapies aimed at transforming the standard of care for autoimmune diseases. Its lead candidate, JADE101, is an antibody designed to inhibit the cytokine APRIL (A PRoliferation-Inducing Ligand) and is being developed for the treatment of immunoglobulin A nephropathy (IgAN). The company builds its pipeline from discovery-stage assets licensed from Paragon Therapeutics and is focused on advancing clinical programs to deliver new treatments for patients with autoimmune conditions.

📋 Description

• Drives timely submission of regulatory submissions including initial trial applications (e.g. IND, CTA) and marketing 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, including identification of regulatory requirements and expectations, as a member of operational study teams.

🎯 Requirements

• Bachelor’s degree from an accredited institution required. • 5–8+ years of pharmaceutical/biotech R&D experience, including 3–5+ years in Regulatory Affairs. • 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. • 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. • Excellent written and verbal communication skills, including the ability to clearly articulate regulatory positions. • Ability to work independently and collaboratively within a matrixed, multidisciplinary environment. • High proficiency in MS Word, Excel, Adobe Acrobat, and regulatory document management systems.

🏖️ Benefits

• Health insurance • Paid time off • Professional development opportunities