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Job Locations US-WI-Madison
Posted Date 1 month ago(6/30/2021 8:54 AM)
FUJIFILM Cellular Dynamics is a leading developer and supplier of human cells used in drug discovery, toxicity testing, stem cell banking, and cell therapy development. We partner with innovators from around the world to combine biologically relevant human cells with the newest technologies to drive advancements in medicine and healthier living. Our technology can be used to create induced pluripotent stem cells (iPSCs) from anyone and followed by the powerful capability to develop into virtually any cell type in the human body. Our proprietary manufacturing system result in inventoried iCell® products and donor-specific MyCell® Products in the quantity, quality, purity, and reproducibility required for drug and cell therapy development.   We are in the market for qualified candidates for the newly created position of Regulatory Affairs Manager.  In this critical, and hands-on role you'll serve as the regulatory project lead and provide regulatory expertise and execution for regulatory activities, including planning, authoring, compiling, and submitting highest-quality regulatory submissions to the regulatory bodies within FCDI timelines and in accordance with regulatory guidelines and health authority requirements.  You will also align with internal and external subject matter experts to ensure effective execution of FCDI’s regulatory strategy.  We'll rely on you as key resource to ensure current knowledge and consistency with global regulatory rules and guidance, providing insight and guidance.
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