Director, Regulatory Operations

Position Overview

Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema, as well as STAR-0310, an OX40 monoclonal antibody antagonist currently in preclinical development for atopic dermatitis (AD) and being explored for other allergic and immunological diseases.

We are seeking a highly motivated and detail-oriented Director of Regulatory Affairs Operations to join our team. This is a key leadership role supporting global regulatory submissions, document management, and cross-functional collaboration to help deliver life-changing medicines to patients. In this pivotal role, you will oversee regulatory operations activities across development programs, ensuring compliant, efficient, and timely regulatory submissions. Reporting directly to the VP of Regulatory Affairs, you will manage the preparation, publishing, and archiving of submissions to global health authorities, guide internal teams on technical and regional requirements, and lead best practices across regulatory systems and processes.

This position is ideal for a seasoned Regulatory Operations leader who thrives in a nimble, hands-on environment and is excited by the opportunity to build and enhance operational infrastructure within a small but rapidly evolving biotech company.

Responsibilities

• Lead the day-to-day regulatory operations activities across assigned programs, ensuring timely, high-quality submissions to global regulatory agencies (FDA, EMA, etc.).
• Oversee preparation, formatting, publishing, and submission of documents for INDs, NDAs, BLAs, CTAs, MAAs, supplements, briefing documents, and more.
• Manage submission processes from planning through archiving, ensuring alignment with internal SOPs and global regulatory standards.
• Serve as subject matter expert on regional and technical submission requirements and regulatory document formatting.
• Provide authoring template training and ongoing support to cross-functional teams.
• Maintain and administer the Electronic Document Management System (EDMS) and Regulatory Affairs SharePoint sites.
• Drive continuous improvement initiatives related to submission tools, templates, processes, and systems.
• Support the Business Development team by providing regulatory documentation and due diligence materials as needed.
• Collaborate cross-functionally with Regulatory Affairs, Clinical, Quality, and CMC to ensure submission readiness and compliance.

Qualifications

• Bachelor’s degree in life sciences or a related discipline required.
• Minimum 8 years in the pharmaceutical/biotech industry, including 7+ years of direct Regulatory Operations experience.
• Proven success managing regulatory submissions with first-pass technical acceptance within the last 4 years.
• Deep knowledge of global regulatory submission types and requirements, including INDs, NDAs, BLAs, CTAs, MAAs, and related documentation.
• Expertise in submission publishing software and document formatting standards (e.g., eCTD).
• Strong experience with Electronic Document Management Systems (EDMS) and SharePoint.
• Solid understanding of ICH, FDA, EMA, and other regional submission guidelines.
• Meticulous attention to detail with strong organizational and quality assurance skills.
• Ability to prioritize and manage multiple high-stakes projects in a dynamic, deadline-driven environment.
• Excellent verbal and written communication skills.
• Collaborative mindset with the ability to work effectively in cross-functional teams.
• Adaptable, solutions-oriented, and comfortable operating in an evolving regulatory landscape.

Astria’s Commitment

At Astria, we are committed to building a team where every Astrian endorses the idea that people bring their authentic self to work.

We embrace a patients-first, people-always culture which strives to ensure all Astrians and our collaborators have a sense of belonging and receive the support they need to thrive.

We invest in our people through our words, our actions, and our values. We are working to develop and implement initiatives that promote inclusion and belonging throughout the organization and foster a culture of openness, respect, and collaboration, where all voices are heard, and everyone is valued for their unique perspectives and contributions.

At Astria, people are our greatest asset, and by fostering an inclusive environment, we all shine brighter. Together we can bring our passion and compassion to the work of delivering life-changing therapies to patients, families, and communities.