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Director, Regulatory Affairs

Cambridge, United States - Remote

Company Overview

Avalyn is a biopharmaceutical company developing inhaled therapies for the treatment of rare respiratory diseases including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, 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 is developing a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s lead program, AP01, is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b Study in progressive pulmonary fibrosis (PPF). Avalyn has initiated a Phase 1b study for its second program, AP02, inhaled nintedanib, that is being developed for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit avalynpharma.com and follow us on LinkedIn.

Position Summary

The Director of Regulatory Affairs will be a senior leader responsible for driving the global regulatory strategy and execution for Avalyn’s development-stage, inhaled drug-device combination products. Reporting to the VP, Regulatory Affairs, the Director 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 deep expertise in rare disease drug development, combination products, and a proven track record of advancing programs from early stages through late-phase clinical development.

Key Responsibilities

  • Strategic Leadership: Develop and lead global regulatory strategies across nonclinical, clinical, CMC, and device components to support product development, registration, and eventual commercialization in key markets (U.S., EU, Canada, APAC, LATAM).
  • Regulatory Filings: Oversee the preparation, review, and submission of regulatory documents including INDs, CTAs, ODDs, annual reports, briefing packages, and other major regulatory submissions. Ensure timely, high-quality execution in alignment with business goals.
  • Health Authority Engagement: Serve as regulatory point of contact for interactions with FDA and other global health authorities. Lead the planning and execution of regulatory meetings and responses to inquiries.
  • Cross-Functional Collaboration: Partner with Clinical Development, Clinical Operations, CMC, Nonclinical, Program Management, and external consultants to align regulatory deliverables and ensure strategic integration of regulatory considerations into program plans.
  • Regulatory Intelligence & Compliance: Monitor evolving global regulatory landscapes, conduct risk assessments, and incorporate new regulations or guidance into regulatory strategy and operations.
  • Operational Oversight: Lead regulatory operations, including document management, submission tracking, and compliance reporting. Oversee regulatory information systems, ensure accurate archiving of correspondence and submissions, and manage vendor/consultant roles where applicable.
  • Team Development: Mentor junior regulatory professionals and support a culture of continuous learning, cross-training, and operational excellence.

Qualifications

  • Advanced degree in life sciences (PhD, PharmD, MS preferred); Bachelor’s degree with extensive experience may be considered.
  • 10+ years of regulatory affairs experience, including leadership of global regulatory strategy and direct authorship of regulatory submissions for investigational and commercial products.
  • Strong experience in rare disease and/or respiratory therapeutic areas highly desirable.
  • Expertise in U.S. FDA regulations and international regulatory requirements, including ICH guidelines and eCTD format.
  • Demonstrated success managing regulatory components of drug-device combination products.
  • Proven track record with INDs, CTAs, and health authority meetings; NDA/MAA experience is strongly preferred.
  • Hands-on experience with orphan drug designation (ODD), fast track, breakthrough therapy, and other expedited pathways.
  • Excellent project management skills with the ability to manage multiple priorities in a fast-paced, growing organization.
  • Strong interpersonal and communication skills; ability to influence across levels and functions.
  • Experience working in small biotech or fast-paced, matrixed environments is a plus.

 

Proposed pay range

$195,000 - $225,000 USD

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