Company Overview

Avalyn is reimagining the future of pulmonary fibrosis treatment with a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, and reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn’s inhaled approach tackles the underlying pathophysiology of pulmonary fibrosis at its source and is designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s AP01 is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b study in progressive pulmonary fibrosis (PPF). AP01 has been assessed in over 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety compared to historical data with existing therapies. The company completed two Phase 1 studies for AP02, inhaled nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF) and is planning a Phase 2 clinical trial. For more information, please visit avalynpharma.com and follow us on LinkedIn.

Position Summary

The Senior Manager / Associate Director, 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 oversee global regulatory submissions, health authority interactions, and cross-functional regulatory planning. This is a critical role for a highly motivated regulatory leader with experience in rare disease drug development, combination products, and a proven track record of advancing programs from early stages through late-phase clinical development.

In addition to leading regulatory activities for assigned development programs, the Senior Manager / Associate Director will contribute to regulatory initiatives that support consistency and operational excellence across the pipeline. This role will collaborate with senior regulatory leadership to strengthen processes, systems, and standards that enable efficient development and compliant global interactions. This position will play a key role in shaping the organization and operation of Avalyn’s regulatory function, ensuring high-quality systems, standards, and practices that enable efficient development, compliant execution, and successful global interactions with health authorities.

Key Responsibilities:

Strategic Leadership:

• Contribute to and help shape global regulatory strategies across nonclinical, clinical, CMC, and device components to support product development and registration in key markets (U.S., EU, Canada, APAC, LATAM).
• Lead strategic elements for assigned programs while partnering with senior regulatory leaders on overarching strategy.
• Translate high-level regulatory strategy into actionable submission plans and timelines.
• Identify regulatory risks and propose mitigation strategies in partnership with senior regulatory leadership.

Regulatory Filings:

• Lead preparation, coordination, and review of regulatory submissions including INDs, CTAs, amendments, annual reports, orphan drug applications, and briefing packages.
• Author and/or oversee preparation of key regulatory documents.
• Ensure submissions are high quality, compliant, and delivered on time.

Health Authority Engagement:

• Support the planning and execution of regulatory meetings, lead development of responses to agency inquiries, and collaborate with global partners to ensure consistent communication.
• Support regulatory interactions with FDA and other global health authorities, including tracking regulatory interactions and correspondence
• May serve as regulatory lead for selected routine agency interactions under senior oversight.

Cross-Functional Collaboration:

• Work closely with Clinical Development, Clinical Operations, CMC, Nonclinical, and Program Management teams to ensure regulatory considerations are fully integrated into program plans.
• Provide clear regulatory guidance and influence decision making across development functions.
• Participate in cross-functional project teams as the regulatory representative for assigned programs, including clinical trial support.

Regulatory Intelligence & Compliance:

• Monitor evolving regulatory requirements and assess their impact on assigned programs.