Regulatory Affairs Manager, CA - KatalystHLS.com Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products. Provide regulatory oversight and guidance to project teams on compliance matters, FDA requirements, clinical study design issues and on timing, logistics and operational recommendations for product development. Develop regulatory submission strategies in agreement with defined product development objectives. Serve as the principal regulatory affairs liaison to FDA and other health authorities for assigned Investigational New Drug (IND) and New Drug Applications (NDA) projects. Prepare and submit IND and NDA applications, as well as various amendments and supplements.
https://www.indeed.com/viewjob?t=regulatory+affairs+manager&jk=c5fa42d1a2ebd955&_ga=2.246150343.257975813.1553548450-2077807285.1533320279
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