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Regulatory Coordinator

UW-MADISON

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At a glance

Compensation
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Location
Remote · US
Work Authorization
Not specified

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Job overview

The Regulatory Coordinator supports imaging-based research studies in the Department of Radiology at the University of Wisconsin-Madison. The role prepares, reviews, and submits regulatory documents and reports, performs quality checks, and assists with audits and compliance reviews. It also contributes to process improvement and collaborates with investigators and research teams. The position is anticipated to be remote, with onsite meetings, training, and audits as requested.

Skills & qualifications

RequiredNice to have

Skills

Regulatory SupportRegulatory Document PreparationRegulatory Document ReviewRegulatory SubmissionsQuality ChecksAudit SupportCompliance ReviewsProcess ImprovementCollaboration

Full job description

JOB REQUIREMENTS: Current Employees: If you are currently employed at any of the Universities of Wisconsin, log in to Workday to apply through the internal application process. Job Category:Academic Staff Employment Type:Regular Job Profile:Regulatory Coordinator Job Summary: The Department of Radiology at the University of Wisconsin-Madison School of Medicine and Public Health is seeking a detail-oriented and motivated Regulatory Coordinator to support a diverse portfolio of imaging-based research studies. This role provides regulatory support across all phases of research, including the preparation, drafting, review, and submission of regulatory documents, applications, and reports, while ensuring compliance with institutional, state, and federal requirements. The coordinator will apply regulatory knowledge across a broad range of study types, perform quality checks, and assist with audits and compliance reviews. This position also contributes to the development and improvement of team processes, procedures, tools, and training, and collaborates closely with investigators, study teams, and research staff to support the department's mission of discovery, education, and excellence in research. This position offers a unique opportunity to support cutting-edge imaging research, including studies involving novel PET radiotracers, while gaining exposure to FDA regulatory submissions and maintenance, such as Drug Master Files (DMFs), Investigational New Drug (IND) applications, amendments, and annual reports. The Department of Radiology offers a dynamic, interdisciplinary environment that integrates advanced imaging technologies with leading research initiatives. Ideal candidates value collaboration, continuous improvement, and service excellence while supporting regulatory operations that enable high-quality, compliant research. ADDITIONAL JOB DETAILS: It is anticipated that this position will be remote and requires work be performed at an offsite, non-campus work location. Must be willing to attend onsite meetings, training, and audits as requested by the department. Successful candidates who address the following Knowledge, Skills, and Abilities in their... For full info follow application link. The University of Wisconsin-Madison is an Equal Opportunity and Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence through diversity and encourage all qualified individuals to apply. If you need to request an accommodation because of a disability, you can find information about how to make a request at the following website: https://employeedisabilities.wisc.edu/disability-accommodation-information-for-applicants/ ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/FFEA1188ACEC4F13

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