Senior Regulatory Project Manager or Regulatory Project Manager

The Michigan IND/IDE Investigator Assistance Program (MIAP) in the University of Michigan Medical School Office of Research is seeking an experienced regulatory professional to join our team. The position may be filled at either the Senior Regulatory Project Manager level (Research Compliance Specialist Senior) or the Regulatory Project Manager level (Research Compliance Specialist Intermediate), depending on the qualifications and experience of the selected candidate.

MIAP provides comprehensive regulatory support, guidance, and education to University of Michigan sponsor-investigators conducting investigator-initiated, FDA-regulated clinical research across all therapeutic areas. We support research involving investigational drugs, biologics, medical devices, and combination products from regulatory strategy development through study closeout, with a focus on the preparation and maintenance of Investigational New Drug (IND) applications and Investigational Device Exemption (IDE) applications.

This role involves managing complex regulatory projects, working with investigators and research teams, and communicating directly with the FDA. Responsibilities include preparing IND and IDE applications and lifecycle submissions, exemption and device risk determination requests, FDA meeting requests and briefing packages, and responses to FDA inquiries. The role also includes reviewing protocols, informed consent documents, and supporting materials; providing regulatory and operational guidance;

supporting U-M institutional review boards, including review of applicable drug, biologic, and device submissions in eResearch; participating in consultations and educational activities; and developing regulatory tools, templates, procedures, and training resources.

This work requires a strong understanding of clinical research and the regulatory framework governing FDA-regulated studies, intellectual curiosity, critical thinking, careful attention to detail, and the ability to translate complex and evolving requirements into clear, practical, and well-reasoned guidance.

MIAP is a collaborative and supportive team that values open discussion, shared learning, and thoughtful problem-solving. Team members manage their work independently while drawing on one another's expertise to address challenging regulatory questions and support innovative medical research at the University of Michigan.

Research Compliance Specialist Senior Responsibilities

Regulatory Project Management 80%

Prepare and submit INDs, IDEs, IND exemption requests, device risk determination requests, and related regulatory submissions

Prepare FDA meeting packages, responses to FDA inquiries, amendments, safety reports, annual reports, and other lifecycle submissions

Critically review regulatory documents, clinical protocols, informed consent documents, and supporting materials for completeness and compliance with applicable requirements

Develop and provide regulatory and operational guidance to investigators and multidisciplinary project teams

Interpret and apply University policies and federal regulations to complex research projects

Collaborate with U-M institutional review boards, Clinical Trials Support Units, the Office of Research and Sponsored Projects, and research consortia to support coordinated regulatory oversight

Monitor and interpret changes in FDA regulations and guidance and communicate relevant updates to investigators, research teams, and other partners

Education and Consultations 15%

Provide regulatory expertise and support to U-M institutional review boards, including review of applicable drug, biologic, and device submissions in eResearch

Provide regulatory education and training to investigators, sponsor-investigators, and other clinical research and regulatory personnel

Provide consultation and guidance to investigators and study teams regarding regulatory issues in clinical research and product development

Participate in professional development and maintain engagement with national regulatory support organizations

Medical Writing and Editing 5%

Create and revise standard operating procedures, tools, templates, guidance documents, and educational materials

Review and edit manuscripts, posters, presentations, and abstracts, as appropriate

Research Compliance Specialist Intermediate Responsibilities

Regulatory Project Management 80%

Assist with the preparation and submission of…