Senior Manager – Regulatory Affairs
Avalyn Pharma
full-time
Posted on:
Location Type: Remote
Location: Massachusetts • United States
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Salary
💰 $163,000 - $182,000 per year
Job Level
About the role
- Support development and execution of global regulatory strategy
- Oversee global regulatory submissions and health authority interactions
- Lead regulatory activities for assigned development programs
- Collaborate with cross-functional teams to integrate regulatory considerations
Requirements
- Experience in regulatory affairs for drug-device combination products
- Experience with rare disease drug development
- Proven track record in late-phase clinical development
- Experience in global regulatory submissions
- Strong understanding of regulatory strategy and compliance
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory affairsglobal regulatory submissionsregulatory strategycompliancedrug-device combination productsrare disease drug developmentlate-phase clinical development
Soft Skills
collaborationleadership