Senior Regulatory Lead, Global Biotech & Inhaled Therapies

Avalyn Pharma Inc.; Boston (MA); On-site; USD 157,000 - 173,000; Full time

Job summary

Avalyn Pharma Inc. is seeking a Senior Regulatory Affairs Manager to lead global regulatory strategy and execution for inhaled drug-device products. You will partner with senior leadership to drive regulatory submissions, health authority interactions, and program planning across development stages.

Reporting to the SVP, Regulatory Affairs, the role emphasizes cross-functional collaboration, process improvement, and delivery of high-quality regulatory deliverables in a fast-paced environment.

Qualifications

• Bachelor's degree in a related field is required.
• 5–8+ years of regulatory affairs experience in pharma/biotech.
• Experience authoring regulatory submissions for INDs/CTAs.
• Experience with global development programs and FDA interactions.

Responsibilities

• Support global regulatory strategies across development programs.
• Coordinate preparation and submission of regulatory filings.
• Support regulatory meetings with FDA and other health authorities.
• Maintain regulatory tracking systems and documentation.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Project management

FDA interactions

Regulatory operations

Strategic planning

Documentation writing

Education

Bachelor's degree

Advanced degree preferred

Tools

SharePoint

eCTD tools

Job description

Avalyn Pharma Inc. is seeking a Senior Regulatory Affairs Manager to lead global regulatory strategy and execution for inhaled drug-device products. You will partner with senior leadership to drive regulatory submissions, health authority interactions, and program planning across development stages.

Reporting to the SVP, Regulatory Affairs, the role emphasizes cross-functional collaboration, process improvement, and delivery of high-quality regulatory deliverables in a fast-paced environment.