Responsibilities: Use your Regulatory Submissions expertise to work with United States and International Regulatory submissions. Create FDA and ICH compliant regulatory submissions. These submissions are complex and are intricately linked into a cohesive product that can be easily reviewed by a regulatory agency Perform detailed quality reviews of published output to ensure compliance with Regulatory Standards and FDA guidances. This includes verification of bookmarks, hypertext links and tables of content in global submissions. Expedite, manage and coordinate a multitude of concurrent interrelated activities for Global Project Teams and/or multiple products in the development of published Global submissions within the required timeliness Prepare Investigative New Drug (IND) safety cover letters and IND amendment submissions to FDA.Requirements
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