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← Avalyn Pharma

Senior Manager, Regulatory Affairs

Avalyn Pharma
Location
Boston, MA
Posted
1 month ago
Department
Regulatory Affairs
What they actually want (must-haves)
  • Bachelor’s degree
  • 5-8 years of regulatory affairs experience in the pharmaceutical, biotechnology, or combination product industry
  • Experience with global clinical trials and regulatory submissions (INDs, CTAs, amendments)
  • Understanding of U.S. FDA regulations and ICH guidelines
  • Ability to collaborate within cross-functional teams
  • Strong project management and organizational skills
Nice to have
  • Advanced degree (e.g., MS, PharmD, PhD) or regulatory affairs training/certification
  • Experience with drug-device combination products
  • Experience with orphan drug or expedited regulatory pathways
  • Experience with regulatory information management systems or SharePoint
  • Experience in a small biotechnology company
What the job really is

The Senior Manager, Regulatory Affairs at Avalyn will support the global regulatory strategy for inhaled drug-device combination products. This role involves contributing to regulatory submissions, health authority interactions, and cross-functional planning to ensure compliance and operational excellence throughout the product development pipeline. The position requires collaboration with various teams and offers opportunities for increased ownership of development programs as responsibilities grow.

Things to weigh
  • No specific benefits listed
  • Salary range provided is $157,000 — $173,000, which may vary based on experience
  • Role involves significant collaboration across multiple teams, which may require strong interpersonal skills
Job score2.6/5
Benefits1/5
Freshness4/5
Career value4/5
Role clarity4/5
Pay transparency0/5

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