Coordinating the planning, preparation and submission of global regulatory CMC-related submissions for clinical and commercial products such as: post approval variations, Marketing Application(s), Annual Reports, Clinical Trial Applications, and amendments. Developing and/or reviewing regulatory documents to ensure that all submissions are complete, accurate and meet relevant requirements. Creating timelines and tracking deliverables to timelines to ensure that all submissions are submitted on-time. Performing regulatory research and drafting reports summarizing regulatory requirements.
https://www.indeed.com/viewjob?t=cmc+regulatory+affairs+associate&jk=ae0ea2c49d00c969&_ga=2.225310618.1458602033.1555018110-2077807285.1533320279
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