# Senior Manager, Regulatory Affairs at Avalyn

- Company: Avalyn
- What the company does: Backed by Norwest.
- Company website: https://www.avalynpharma.com/
- Type: Startups
- Level: Senior
- Location: Boston, MA
- Work setup: On-site
- Posted: 2026-08-17
- Apply by: 2026-10-12
- Apply: https://www.avalynpharma.com/culture-careers/?gh_jid=5393503008#job-opportunities
- Page: https://www.1752.vc/careers/jobs/avalyn-senior-manager-regulatory-affairs/

## 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

Tags: Regulatory Affairs