Backed by Norwest.
About the role
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.
What they're looking for
- 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
- 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
More about this role
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...
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