Regulatory Project Manager

University Of Michigan-posted about 1 year ago
Full-time • Senior
Remote • Ann Arbor, MI
Educational Services
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The Regulatory Project Manager at the University of Michigan's Michigan Institute for Clinical & Health Research (MICHR) plays a crucial role in providing regulatory support and guidance for clinical research involving FDA-regulated products. This position focuses on ensuring compliance with regulatory requirements, preparing and submitting Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications, and offering educational resources to faculty investigators. The role is integral to advancing clinical and translational science by improving the efficiency and effectiveness of research operations.

  • Responsible for the preparation and submission of INDs and IDEs and related submissions including preparation of meeting packages, responses to FDA inquiries, and life-cycle maintenance submissions to FDA.
  • Critically review submission documents and clinical trial documents such as clinical protocols and informed consent documents to ensure compliance with regulatory requirements.
  • Assist with developing and providing regulatory and operational guidance and support to investigators by interacting with project teams.
  • Provide regulatory expertise and support to the UM Institutional Review Board.
  • Assist in providing regulatory education and training to investigators, sponsor-investigators, clinical research monitors, and other research/regulatory personnel.
  • Provide guidance and support to investigators and study teams related to regulatory issues in product development.
  • Create and revise SOPs, develop tools, documents, and resources for standard practice, templates, and education/training materials.
  • Review manuscripts, posters, presentations, and abstracts as appropriate.
  • Bachelor's degree in a scientific or technical discipline.
  • 5 years or more of professional experience in research compliance or FDA regulated research administration or equivalent in educational training and background.
  • Knowledge of the FDA regulations, policies, and guidance related to investigational drugs and devices.
  • Attention to detail and ability to work independently with minimal supervision.
  • Effective communication skills in various settings: one-on-one, small groups, and large groups.
  • 2-5 years' experience in the regulatory field, specifically in the submission of INDs and IDEs.
  • Regulatory Affairs Certification (RAC).
  • Hybrid work options with occasional travel to Ann Arbor, MI.
  • Commitment to Inclusion, Diversity, Equity, Accessibility, and belonging.
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