Global Regulatory Submissions Maintenance

Rahmendaten

<span style="font-size: 12.0pt;"><span style="font-family: Calibri , sans-serif;"><strong><span style="">Framework data:</span></strong></span></span><br> <span style="font-size: 12.0pt;"><span style="font-family: Calibri , sans-serif;"><span style="">Start date: 31.01.2024</span></span></span><br> <span style="font-size: 12.0pt;"><span style="font-family: Calibri , sans-serif;"><span style="">End date: 31/05/2024</span></span></span><br> <span style="font-size: 12.0pt;"><span style="font-family: Calibri , sans-serif;"><span style="">Workload: 40 H/week</span></span></span><br> <span style="font-size: 12.0pt;"><span style="font-family: Calibri , sans-serif;"><span style="">Location: Remote</span></span></span><br> <br> <span style="font-size: 12.0pt;"><span style="font-family: Calibri , sans-serif;"><strong><span style="">Tasks:</span></strong></span></span> <ul> <li style="margin: 0.0cm 0.0cm 0.0cm 36.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Calibri , sans-serif;"><span style="">Responsible for the planning, coordination and monitoring of regulatory submissions on a global level.</span></span></span> <li style="margin: 0.0cm 0.0cm 0.0cm 36.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Calibri , sans-serif;"><span style="">Ensure compliance with all relevant regulations and guidelines throughout the submission process</span></span></span> <li style="margin: 0.0cm 0.0cm 0.0cm 36.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Calibri , sans-serif;"><span style="">Maintain and update all required documentation for regulatory submissions.</span></span></span> <li style="margin: 0.0cm 0.0cm 0.0cm 36.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Calibri , sans-serif;"><span style="">Ensure consistency and accuracy of all documents in accordance with applicable regulations.</span></span></span> <li style="margin: 0.0cm 0.0cm 0.0cm 36.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Calibri , sans-serif;"><span style="">Working closely with internal departments such as R&D, Quality Control and Clinical Research to gather relevant information for submissions.</span></span></span> <li style="margin: 0.0cm 0.0cm 0.0cm 36.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Calibri , sans-serif;"><span style="">Ensure clear communication and coordination between different teams.</span></span></span> <li style="margin: 0.0cm 0.0cm 0.0cm 36.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Calibri , sans-serif;"><span style="">Monitor and be aware of changes in regulatory requirements and ensure all documentation is updated accordingly.</span></span></span> <li style="margin: 0.0cm 0.0cm 0.0cm 36.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Calibri , sans-serif;"><span style="">Participate in training and continuing education to maintain up-to-date knowledge of evolving regulations.</span></span></span> </ul> <br> <span style="font-size: 12.0pt;"><span style="font-family: Calibri , sans-serif;"><strong><span style="">Qualifications</span></strong><span style="">:</span></span></span> <ul> <li style="margin: 0.0cm 0.0cm 0.0cm 36.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Calibri , sans-serif;"><span style="">Bachelor's degree in Pharmacy, Science or related field.</span></span></span> <li style="margin: 0.0cm 0.0cm 0.0cm 36.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Calibri , sans-serif;"><span style="">At least 3 years of experience in Global Regulatory Submissions Maintenance, preferably in the pharmaceutical industry.</span></span></span> <li style="margin: 0.0cm 0.0cm 0.0cm 36.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Calibri , sans-serif;"><span style="">Sound knowledge of international drug approval regulations and procedures.</span></span></span> <li style="margin: 0.0cm 0.0cm 0.0cm 36.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Calibri , sans-serif;"><span style="">Excellent communication and coordination skills.</span></span></span> <li style="margin: 0.0cm 0.0cm 0.0cm 36.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: Calibri , sans-serif;"><span style="">Ability to work independently and manage multiple projects simultaneously.</span></span></span> </ul>