Director, Regulatory Affairs

<div class="content-intro"><p>At Avalo (ahh-vah'-low), we are 100% focused on developing treatments for immune-mediated inflammatory diseases with large unmet needs that affect millions worldwide. Our strategy is to develop medicines that target the IL-1β pathway, which is a central driver of the inflammatory process.</p> <p>We share a commitment to teamwork, passion for science, and dedication to patients suffering from acute and chronic inflammatory disorders. Our collective expertise in discovery, development, and regulatory approvals is evidenced in our strong individual track records of advancing multiple therapeutic programs to successful commercialization.</p></div><p><strong>Position Summary:</strong></p> <p>Avalo Therapeutics is seeking a strategic and execution-focused Director, Regulatory Affairs, to provide global regulatory leadership for abdakibart (AVTX-009), the company's lead asset, as it advances into Phase 3, and potential registration</p> <p>The Director will serve as a key member of cross-functional development teams, providing regulatory leadership across clinical development, regulatory submissions, health authority interactions, and lifecycle management activities. The ideal candidate will bring a balanced mix of strategic and operational regulatory expertise.</p> <p><strong>Essential Duties and Responsibilities:</strong></p> <ul> <li>Design, lead, and implement global regulatory strategies to support the development, registration, and lifecycle management of assigned programs.</li> <li>Serve as the Regulatory Affairs representative on cross-functional project teams and provide proactive, strategic guidance to advance program objectives.</li> <li>Evaluate evolving regulatory requirements, competitive developments, and emerging scientific trends, and assess potential impacts on development strategy.</li> <li>Identify regulatory risks, develop mitigation plans, and communicate recommendations to project teams and senior leadership.</li> <li>Contribute to regulatory development plans supporting advancement throughout development to commercialization.</li> <li>Collaborate with senior regulatory leadership on major strategic initiatives, including FDA and global health authority meetings, registration strategy, BLA planning, and labeling activities.</li> <li>Lead the planning, preparation, review, and submission of regulatory documents throughout the product lifecycle.</li> <li>Provide hands-on leadership for a broad range of U.S. and global regulatory submissions, such as DSURs, protocol amendments, information amendments, INDs, CTAs, labeling, etc.</li> <li>Ensure submissions are scientifically accurate, strategically aligned, compliant, and delivered on schedule.</li> <li>Lead and co