Principal Reg Affairs Assistant

<p style="text-align:left"><b>Work Schedule</b></p>Standard (Mon-Fri)<p style="text-align:inherit"></p><p style="text-align:left"><b>Environmental Conditions</b></p>Office<p style="text-align:inherit"></p><p style="text-align:left"><b><u>Job Description</u></b></p><p style="text-align:inherit"></p><ul><li><span>Supports the preparation of documentation and submissions under EUCTR guidance.</span></li><li><span>Coordinates and manages client deliverables supporting regulatory compliance.</span></li><li><span>Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects.</span></li><li><span>Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines.</span></li><li><span>Evaluates client needs in relationship to overall project timelines, quality and delivery.</span></li><li><span>Engages with other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed</span></li><li><span>Provides project specific services, documentation and coordination of projects and supports reporting of same to management, internal and external clients.</span></li><li><span>Supports preparation of bids and proposals; generates, tracks and analyses data for proposal, revisions, contract modifications and bid defenses.</span></li></ul><p><span> </span></p><p><span>Education and Experience:</span></p><p><span>Bachelor&#39;s or Master’s degree or equivalent and relevant formal academic / vocational qualification</span></p><p><span><span>Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1&#43; years)</span></span></p><p></p><p></p><p></p><p></p>