Regulatory Submission Coordinator

<h2>Job Overview:</h2><p style="margin: 0px;">♦ Under the direction of senior staff, assist with the formatting and compilation of regulatory <br />submissions through such tasks as entering information into Tables of Contents and creating <br />tabs and submission labels. <br />♦ Provide support assistance to senior staff in the upkeep of regulatory authority submission and <br />correspondence logs (add entries to Tables of Contents, file submission letters and other <br />correspondence). <br />♦ Generate routine submission cover letters to regulatory authorities and clients. <br />♦ Track, inventory and organize individual components of regulatory submissions. <br />♦ Perform document acceptability checks of submission components. <br />♦ Liaise with the Publishing group in the generation of submissions. <br />♦ Provide support assistance to senior staff in the oversight, final preparation and generation of <br />submission documents. <br />♦ Perform a quality check of final submission documents. <br />♦ Update status reports and tracking sheets of ongoing and pending regulatory projects with input <br />provided by senior staff. <br />♦ Organise shipping of documentation to clients, regulatory authorities and within Covance. <br />♦ Perform other job functions, such as word processing, as needed to accomplish the above listed <br />duties. <br />♦ Perform other activities as required by management.</p><h2>Education/Qualifications:</h2><p style="margin: 0px;">Bachelor’s Degree in Life Sciences or equivalent</p><h2>Experience:</h2><p style="margin: 0px;">♦ Excellent verbal and written communication skills. <br />♦ Computer literacy in basic functions (Word, Excel) <br />♦ Good planning and organizational skills; detail oriented. <br />♦ Flexibility, ability to switch back and forth between multiple projects/tasks.</p>