Director Regulatory Affairs Data Products

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Director, Regulatory Affairs (Data Products)
Responsibilities: Ensure that software and data products are developed and validated to standards required for FDA-regulated products and/or for data included as part of a drug or diagnostic regulatory approval submission (e.g. NDA, PMA). Serve as the internal regulatory expert on software and data/database products. Provide internal training as needed on FDA requirements. Develop regulatory strategy for complex projects, including internal FMI regulatory needs as well as biopharma partner regulatory submissions. Prepare and review FDA submissions including pre-submission documents, Significant Risk Determination Requests, IDE/IND applications, premarket applications (NDA, PMA, BLA) and post-market reporting. Draft submission documents with other subject matter experts as needed. Review and edit technical documents to be included in submissions, which may include software validation protocols and reports and/or other software development documentation. Monitor external activities and develop FMI thought leadership around the use of real-world evidence for oncology regulatory use-cases, including for real-world control arms. Lead FDA interactions including telephone calls and face-to-face meetings. Participate in agency-sponsored working groups around real-world data and evidence. Interact with external partners for companion diagnostic development or support for partner drug filings. Review change control documentation and file appropriate FDA notification (sPMA, 30-day notice, etc.). Partner with product and software development teams focused on development of real-world data products, including databases that have merged comprehensive genomic profile results with clinical outcome data. Supervise and mentor other members of the Regulatory Affairs team.

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