Senior Regulatory Project Manager or Regulatory Project Manager

How to ApplyA cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and describe the skills and experience that directly relate to this role. Applicants should highlight relevant experience with academic clinical research, investigator-initiated research, and clinical research involving Investigational New Drug applications (INDs) or Investigational Device Exemptions (IDEs), research compliance, or regulatory affairs.Job SummaryThe 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.Responsibilities*Research Compliance Specialist Senior ResponsibilitiesRegulatory Project Management 80%Prepare and submit INDs, IDEs, IND exemption requests, device risk determination requests, and related regulatory submissionsPrepare FDA meeting packages, responses to FDA inquiries, amendments, safety reports, annual reports, and other lifecycle submissionsCritically review regulatory documents, clinical protocols, informed consent documents, and supporting materials for completeness and compliance with applicable requirementsDevelop and provide regulatory and operational guidance to investigators and multidisciplinary project teamsInterpret and apply University policies and federal regulations to complex research projectsCollaborate with U-M institutional review boards, Clinical Trials Support Units, the Office of Research and Sponsored Projects, and research consortia to support coordinated regulatory oversightMonitor and interpret changes in FDA regulations and guidance and communicate relevant updates to investigators, research teams, and other partnersEducation and Consultations 15%Provide regulatory expertise and support to U-M institutional review boards, including review of applicable drug, biologic, and device submissions in eResearchProvide regulatory education and training to investigators, sponsor-investigators, and other clinical research and regulatory personnelProvide consultation and guidance to investigators and study teams regarding regulatory issues in clinical research and product developmentParticipate in professional development and maintain engagement with national regulatory support organizationsMedical Writing and Editing 5%Create and revise standard operating procedures, tools, templates, guidance documents, and educational materialsReview and edit manuscripts, posters, presentations, and abstracts, as appropriateResearch Compliance Specialist Intermediate ResponsibilitiesRegulatory Project Management 80%Assist with the preparation and submission of INDs, IDEs, IND exemption requests, and device risk determination requests under the guidance of senior regulatory staffAssist with FDA meeting packages, responses to FDA inquiries, amendments, safety reports, annual reports, and other lifecycle submissionsReview clinical protocols, informed consent documents, and supporting materials for regulatory completeness and complianceProvide regulatory and operational support to investigators and multidisciplinary research teamsApply knowledge of University policies and federal regulations to assigned regulatory workCollaborate with U-M institutional review boards, Clinical Trials Support Units, the Office of Research and Sponsored Projects, and research consortia to support coordinated regulatory oversightMonitor changes in FDA regulations and guidance with support from senior regulatory staff and communicate relevant updates to project teamsEducation and Consultations 15%Participate in regulatory consultations and provide support to investigators and study teamsAssist with regulatory education and training for investigators, sponsor-investigators, and other clinical research and regulatory personnelParticipate in professional developmentMedical Writing and Editing 5%Assist with creating and revising standard operating procedures, tools, templates, guidance documents, and educational materialsReview and edit manuscripts, posters, presentations, and abstracts, as appropriateRequired Qualifications*Research Compliance Specialist Senior Required QualificationsBachelor's degree in a scientific or technical discipline, or an equivalent combination of education and experienceFive or more years of professional experience in research compliance, FDA-regulated research administration, or a related area, or an equivalent combination of education and experienceExcellent understanding of clinical research and knowledge of FDA regulations, policies, and guidance applicable to investigational drugs, biologics, and medical devicesAbility to evaluate relevant information, apply appropriate regulatory principles, and exercise sound judgmentStrong attention to detail and organizational skillsAbility to manage complex regulatory work independently and responsibly with minimal supervisionAbility to collaborate effectively with colleagues and partners across the organizationStrong written and verbal communication skills across a variety of professional settings and audiencesAdvanced knowledge of medical and scientific terminologyResearch Compliance Specialist Intermediate Required QualificationsBachelor's degree in a scientific or technical discipline, or an equivalent combination of education and experienceAt least two years of experience in research compliance, FDA-regulated research administration, regulatory affairs, or a related field, or an equivalent combination of education and experienceStrong foundation in clinical research and working knowledge of FDA regulations, policies, and guidance applicable to investigational drugs, biologics, and medical devicesAbility to evaluate relevant information and apply established regulatory principles and decision-making criteriaStrong attention to detail and organizational skillsAbility to work independently on assigned responsibilities while seeking guidance when appropriateAbility to collaborate effectively with colleagues and partners across the organizationStrong written and verbal communication skills across a variety of professional settingsProficiency with medical and scientific terminologyDesired Qualifications*Research Compliance Specialist Senior Desired QualificationsDirect experience preparing and submitting INDs, IDEs, or related FDA submissionsExperience applying University policies and federal regulations in an academic research environmentRegulatory Affairs Certification (RAC-Drugs or RAC-Devices), or an advanced degree in regulatory affairs or a related fieldResearch Compliance Specialist Intermediate Desired QualificationsExperience assisting with preparing and submitting INDs, IDEs, or related FDA submissionsExperience applying University policies and federal regulations in an academic research environmentRegulatory Affairs Certification (RAC-Drugs or RAC-Devices), or an advanced degree in regulatory affairs or a related fieldModes of WorkPositions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.Underfill StatementThis position is posted at the Research Compliance Specialist Senior level and may be underfilled at the Research Compliance Specialist Intermediate level depending on the qualifications of the selected candidate.Background ScreeningMichigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third-party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Reporting Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments and transfers from other U-M campuses.U-M EEO StatementThe University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.Job Opening ID284057Working TitleSenior Regulatory Project Manager or Regulatory Project ManagerJob TitleResearch Compliance Spec SrWork LocationAnn Arbor CampusAnn Arbor, MIModes of Work Hybrid Mobile/Remote Full/Part TimeFull-TimeRegular/TemporaryRegularFLSA StatusExemptOrganizational GroupMedical SchoolDepartmentMM Regulatory Affairs-MIAPPosting Begin/End Date10/08/2026 - 10/22/2026Career Interest Research