About Avalyn:
Avalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn’s AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has demonstrated encouraging safety and clinical activity across Phase 1b and an ongoing, multi-year open-label extension trial, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Avalyn’s AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA-IPF, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies. For more information, please visit avalynpharma.com and follow the company on LinkedIn.
Position Summary:
The Senior Manager, Regulatory Affairs will support the development and execution of the global regulatory strategy and execution for Avalyn’s development-stage, inhaled drug-device combination products. Reporting to the SVP, Regulatory Affairs, this position will contribute to global regulatory submissions, health authority interactions, and cross-functional regulatory planning to support product development activities. This role is well suited for a highly motivated regulatory professional who is looking to expand their regulatory leadership capabilities while supporting programs from early stages through late-phase clinical development.
The Senior Manager will primarily support senior regulatory leadership in the planning and execution of regulatory activities across the development pipeline. The role will contribute to regulatory initiatives that promote consistency, operational excellence, and compliance across programs, including support for regulatory processes, systems, and standards. As experience and responsibilities grow, the individual will have the opportunity to assume increasing ownership of an assigned development program under guidance of senior regulatory leadership. This position will work collaboratively across functions to help ensure high-quality regulatory deliverables and effective interactions with global health authorities.
Responsibilities:
Strategic & Regulatory Program Support
- Support the development and execution of global regulatory strategies across nonclinical, clinical, CMC, and device components for Avalyn's development programs.
- Translate regulatory strategy into actionable plans, timelines, and deliverables.
- Identify regulatory risks and support development of mitigation strategies in partnership with senior regulatory leadership.
- Provide regulatory support across multiple development programs and portfolio initiatives.
Regulatory Filings & Health Authority Interactions
- Coordinate preparation, review, and submission of regulatory filings, including INDs, CTAs, amendments, annual reports, orphan drug applications, briefing packages, and other global submissions.
- Author and/or contribute to key regulatory documents and submission content.
- Support Phase 3 and marketing application readiness activities.
- Support regulatory meetings and interactions with FDA and other global health authorities, including preparation of responses and follow-up activities.
- Ensure submissions and regulatory communications are high quality, compliant, and delivered on time.
Regulatory Operations, Systems, & Compliance
- Maintain regulatory tracking systems, dashboards, and tools used to manage submissions, commitments, correspondence, and key milestones.
- Support organization and maintenance of Regulatory Affairs documentation within SharePoint and other document management systems.
- Manage regulatory operational activities, including submission tracking, document management, compliance reporting, and archiving.
- Monitor evolving regulatory requirements and contribute to process improvements, standards, and best practices that support compliance and operational excellence.
- May serve as regulatory lead for selected routine agency interactions under senior oversight.
Cross-Functional Collaboration & Team Contribution
- Work closely with Clinical Development, Clinical Operations, CMC, Nonclinical, Quality, and Program Management teams to ensure regulatory considerations are integrated into program plans.
- Participate in cross-functional project teams as the regulatory representative for assigned programs and development activities.
- Contribute to a collaborative and high-performing regulatory environment and provide guidance to junior team members as appropriate.
- Build increasing responsibility for assigned development programs over time under the guidance of senior regulatory leadership.
Qualifications:
- A minimum of a Bachelor’s degree is required; an Advanced degree (e.g., MS, PharmD, PhD, etc.) or regulatory affairs training/certification is preferred
- A minimum of 5-8 plus years of regulatory affairs experience within the pharmaceutical, biotechnology, or combination product industry, with operational support of global clinical trials, and direct authorship of regulatory submissions for investigational and commercial products.
- Experience supporting global development programs across one or more stages of clinical development, with hands-on preparation and maintenance of regulatory submissions (e.g., INDs, CTAs, amendments, annual reports, and health authority meeting materials).
- Working knowledge of drug-device combination products and their unique regulatory considerations is desirable.
- Solid understanding of U.S. FDA regulations, ICH guidelines, and eCTD submission requirements; experience with orphan drug, expedited, or other special regulatory pathways is a plus.
- Experience supporting regulatory interactions with FDA and/or other global health authorities.
- Demonstrated ability to collaborate effectively within cross-functional teams, including Clinical Development, Clinical Operations, CMC, Nonclinical, Quality, and Program Management.
- Strong project management, organizational, and communication skills, with demonstrated ability to manage multiple priorities and deadlines in a fast-paced environment.
- Experience with regulatory information management systems, document management platforms, and/or SharePoint preferred.
- Experience in a small biotechnology company or matrixed environment is desirable.
