EU Submission Hub Søborg, Denmark Are you looking for an exciting opportunity where you can make a real difference? Would you like to join a dynamic international team where no two days are the same? If you thrive in a collaborative environment across cultures, this could be your next career step. Your new role As a Regulatory Submission Professional, you will play a critical role in managing and coordinating clinical trial submission activities within the EU. You will work in a fast-paced environment with multiple stakeholders and tight timelines, ensuring high-quality and compliant submissions. Your main responsibilities will include: <ul> <li style="text-align:justify;line-height:15.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif;color:black">Working on process optimization for CTA submissions within a team and stakeholders from other teams </li> <li style="text-align:justify;line-height:15.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif;color:black">Working closely with various submission teams across the organization and all countries in Europe</li> <li style="text-align:justify;line-height:15.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif;color:black">Managing initial clinical trial application submissions in the EU according to the Clinical Trial Regulation (EU CTR) and all changes during the life cycle of clinical trials</li> <li style="text-align:justify;line-height:15.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif;color:black">Maintaining documents in the Clinical Trial Information System (CTIS) and ensuring accurate data about clinical trials</li> <li style="text-align:justify;line-height:15.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif;color:black">Coordinating responses for requests for information from Health Authorities and Ethics Committees</li> <li style="text-align:justify;line-height:15.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif;color:black">Ensuring timely submissions in CTIS and contributing to project team decisions</li> <li style="text-align:justify;line-height:15.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif;color:black">Shaping the future setup of new processes for submitting Clinical Trial Applications (CTAs)</li> <li style="text-align:justify;line-height:15.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif;color:black">Collaborating with different IT platforms, such as Veeva Vault RIM and Vault Clinical (COSMOS)</li> </ul> Your new department You will join the EU Submission Hub – a newly established virtual team with colleagues based in Denmark, Poland, and India. The team focuses on clinical trial submissions across the EU and consists of 14 employees working closely with stakeholders across headquarters functions and EU/EEA countries. The EU Submission Hub is anchored in the RQ&C Operations VP area. Team members are located in Søborg (Denmark) and Warsaw (Poland), working in a highly collaborative and international environment. Your skills and qualifications To succeed in this role, we expect you to bring the following: <ul style="margin-bottom:0.0in;margin-top:0.0px" type="disc"> <li style="color:windowtext;text-align:justify;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:2.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif">A Master’s degree in life sciences or a relevant field</li> <li style="color:windowtext;text-align:justify;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:2.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif">A minimum of 3 years of experience working with clinical trials and submissions</li> <li style="color:windowtext;text-align:justify;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:2.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif">Strong understanding of EU Clinical Trial Regulation 536/2024 (EU CTR)</li> <li style="color:windowtext;text-align:justify;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:2.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif">Experience with Vault RIM and Vault Clinical (Veeva platforms) will be considered an advantage</li> <li style="color:windowtext;text-align:justify;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:2.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif">Experience working with CTIS, including document uploads and knowledge of Part I and Part II structures, is a strong advantage</li> </ul> Additionally, you demonstrate: <ul style="margin-bottom:0.0in;margin-top:0.0px" type="disc"> <li style="color:windowtext;text-align:justify;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:2.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif">Experience with process improvement and optimization initiatives</li> <li style="color:windowtext;text-align:justify;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:2.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif">Strong organizational skills and attention to detail</li> <li style="color:windowtext;text-align:justify;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:2.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif">The ability to work effectively under pressure and manage multiple priorities</li> <li style="color:windowtext;text-align:justify;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:2.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif">Excellent communication skills in English, both written and spoken</li> <li style="color:windowtext;text-align:justify;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:2.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif">A proactive mindset, with the ability to work independently and drive results</li> </ul> As a person, you thrive in a collaborative environment and enjoy working across cultures in a virtual team setup. You bring a structured approach, curiosity for continuous learning, and a strong focus on delivering high-quality outcomes. Working at Novo Nordisk Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations. What we offer There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind. Salary and Benefits: The Annual Base Salary ranges from 570,200.00 to 838,100.00 DKK, corresponding to the level of the position. The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience. Incentives and Benefits: The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks. Learn more about our Reward Philosophy <a title="https://www.novonordisk.com/careers/working-at-novo-nordisk/total-rewards-benefits.html" href="https://www.novonordisk.com/careers/working-at-novo-nordisk/total-rewards-benefits.html">here</a> Deadline 23 July 2026 Please note that applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible. You do not need to attach a cover letter, but please include a few sentences about your motivation in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our applicants. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Regulatory Submission Professional - Clinical Trial Submissions in EU (Søborg, Capital Region of Denmark, DK) @ novonord

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