Coord Reg Sub

<h2>Job Overview:</h2><p style="margin: 0px;">Responsible for providing support and assistance, under the direction of senior staff, in the<br />compilation and maintenance of clinical trials and marketing applications for submission to regulatory authorities.</p><h2>Education/Qualifications:</h2><p style="margin: 0px;">Bachelor’s or master's Degree in Life Sciences or equivalent</p><h2>Experience:</h2><p style="margin: 0px;">♦ Experience in HGRAC and CTA/IND appication preferred.</p><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 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>