PhD degree in Regulatory Affairs, Chemical Engineering, Life Sciences or related degree and completion of a universitylevel course, research project, internship, thesis, or one year of experience involving the following Utilizing regulation, Health Agency guidance, and past experiences to create regulatory documents in a document management system; Utilizing regulation, Health Agency guidance and past experiences to create responses to health agency inquiries in a document management system; Authoring, reviewing, and tracking regulatory submission in a document management system; Leveraging IVD science and technical background to develop and review regulatory documents; Interpreting and applying regulations and health agency guidance in regulatory strategy development and planning; and Employing current Good Manufacturing Practices cGMP manufacturing compliance knowledge to author and respond to agency questions for regulatory submissions in a document management system.
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