FDA IND-IDE Specialist

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Primary Purpose of Organizational Unit

Research Compliance Services ( RCS ) supports the Office of the Vice Chancellor for Research ( OVCR ). RCS enables and protects UNC
-Chapel Hill`s $1 billion research enterprise by ensuring adherence to applicable regulations, policies, and ethical standards. In alignment with the OVCR `s mission to grow and support research through strategic leadership, infrastructure development, and external engagement, our unit provides essential oversight and guidance to facilitate compliant research practices. By working collaboratively with researchers and administrative units, we help mitigate risk, promote integrity, and uphold the standards necessary to advance the University`s varied and interdisciplinary research portfolio.

Position Summary

The temporary FDA IND / IDE Specialist is responsible for the organization, coordination, review, and submission of regulatory documents supporting Investigational New Drug ( IND ) applications, Investigational Device Exemption ( IDE ) applications, amendments, supplements, annual reports, and related FDA communications. This role ensures compliance with applicable FDA regulations, Good Clinical Practice ( GCP ), and other regulatory requirements governing clinical research involving drugs, biologics, and medical devices.

The specialist collaborates with the Clinical Trials Quality Assurance team and may interact with clinical research teams to ensure regulatory documents within regulatory submissions meet all submission requirements. This position is important to the department’s goal of increasing the audits we complete as well as continuing to provide excellent customer service. Because audits are generally scheduled and FDA submissions are not, it is challenging to manage the often-competing deadlines.

Hiring a Temporary position to assist with FDA submissions will allow the auditors to better focus on audit completion. This increases our customer satisfaction as it allows us to complete audits in a timely manner. Additionally, hiring a Temporary position allows the department to make the best use of its resources because this will allow the higher paid auditors to focus on audit specific work.

• 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.
• 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.
• 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…