Senior Manager, Regulatory Affairs

The role

The Senior Manager, Regulatory Affairs will support the development and execution of global regulatory strategy for inhaled drug-device combination products. This role involves contributing to global regulatory submissions, health authority interactions, and cross-functional regulatory planning.

What you will do

• Support the development and execution of global regulatory strategies across nonclinical, clinical, CMC, and device components.
• Translate regulatory strategy into actionable plans, timelines, and deliverables.
• Identify regulatory risks and support development of mitigation strategies.
• Coordinate preparation, review, and submission of regulatory filings including INDs, CTAs, amendments, annual reports, and orphan drug applications.
• 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.
• Maintain regulatory tracking systems, dashboards, and tools.
• Support organization and maintenance of Regulatory Affairs documentation within SharePoint and other document management systems.
• Work closely with Clinical Development, Clinical Operations, CMC, Nonclinical, Quality, and Program Management teams.

Required qualifications

• A minimum of a Bachelor’s degree
• A minimum of 5-8 plus years of regulatory affairs experience within the pharmaceutical, biotechnology, or combination product industry
• Operational support of global clinical trials
• Direct authorship of regulatory submissions for investigational and commercial products
• Experience supporting global development programs across one or more stages of clinical development
• Hands-on preparation and maintenance of regulatory submissions (e.g., INDs, CTAs, amendments, annual reports, and health authority meeting materials)
• Solid understanding of U.S. FDA regulations, ICH guidelines, and eCTD submission requirements
• Experience supporting regulatory interactions with FDA and/or other global health authorities
• Demonstrated ability to collaborate effectively within cross-functional teams
• Strong project management, organizational, and communication skills

Nice to have

• Advanced degree (e.g., MS, PharmD, PhD, etc.)
• Regulatory affairs training/certification
• Working knowledge of drug-device combination products and their unique regulatory considerations
• Experience with orphan drug, expedited, or other special regulatory pathways
• Experience with regulatory information management systems, document management platforms, and/or SharePoint
• Experience in a small biotechnology company or matrixed environment

About the company

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.