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Regulatory Affairs Analyst I
Essential Duties and ResponsibilitiesNothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. With supervision, author and compile regulatory submissions in accordance with applicable ICH, CFR, and FDA guidance within specified timelines. This includes but is not limited to ANDA, PAS, CBE and Annual report submissions. Compile high-quality submissions in eCTD format in compliance with applicable regulations and FDA guidance employing use of submission publishing tools and software Participate in meetings and interact with members of the project team and sub-teams to drive submission timelines and determine risks to filing, escalating to managemen


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