Avalyn Pharma

Revolutionizing respiratory care with every breath

Senior Manager – Regulatory Affairs

ComplianceComplianceFull TimeRemoteTeam 11-50H1B No SponsorCompany SiteLinkedIn

Location

Massachusetts

Posted

18 days ago

Salary

$163K - $182K / year

Bachelor DegreeEnglish

Job Description

• 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

Job 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

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