FDA IND-IDE Specialist

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  IND Responsibilities:
  
  
  • Organize, compile, review, and submit IND applications, amendments, safety reports, annual reports, and FDA correspondence.
  • Coordinate cross-functional contributions for Chemistry, Manufacturing, and Controls (CMC), nonclinical, clinical, and investigator information sections.
  • Ensure IND submissions comply with FDA regulations, guidance documents, and eCTD requirements.
  • Track submission timelines and FDA review milestones.
  • Support responses to FDA information requests, clinical holds, and deficiency letters.
  • Maintain regulatory submission archives and documentation.
  
  
  
  
  
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  IDE Responsibilities:
  
  
  • Organize and submit IDE applications, supplements, amendments, progress reports, and device-related FDA communications.
  • Perform a cursory review of device development documentation, risk analyses, and clinical investigation plans.
  • Coordinate with the clinical research teams to support IDE submissions.
  • Ensure compliance with FDA device regulations and investigational device requirements.
  • Monitor IDE approvals, modifications, and post-approval obligations.
  
  
  
  
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  Regulatory Compliance:
  
  
  • Interpret FDA regulations and guidance documents relevant to clinical investigations.
  • Ensure compliance with:
    
    
    • 21 CFR Part 312 (Investigational New Drug Applications)
    • 21 CFR Part 812 (Investigational Device Exemptions)
    • 21 CFR Parts 50, 54, and 56
    • 
      ICH-GCP Guidelines
    • Applicable FDA electronic submission requirements
    
    
    
    
  • Support inspection readiness activities and regulatory audits.
  • Maintain accurate records of regulatory submissions and approvals.
  • Provide submission status updates to project leadership.
  
  
  
  

Not Applicable.