About this role
Research Operations & Compliance Måløv, Denmark Are you passionate about regulatory submission, working across areas, and being part of a dynamic department? Your new position As a Regulatory Submission Professional, you will coordinate the preparation of submission-ready nonclinical documentation for clinical trial and marketing authorization applications in the US, EU and other global markets. Importantly, you will play a central role in the migration of nonclinical documents related to acquisitions driving process improvement initiatives to ensure efficient and compliant integration.
You will use your understanding of submission packages, including study reports and administrative regional documents, to bring together contributions from nonclinical project managers, document owners, Regulatory Affairs and publishing colleagues. Your key responsibilities will include: Timely preparing accurate and high-quality nonclinical submission packages in close collaboration with Nonclinical Project Managers and other contributors. Supporting integrations of acquisitions by streamlining processes and coordinating the migration of regulatory nonclinical documents and data into the appropriate systems.
Coordinating with Regulatory Affairs and global publishing colleagues to align requirements, timelines and deliverables across regions. Drive process improvement and optimization initiatives to enhance automation, efficiency, quality, and compliance. The position requires you to independently manage a variety of complex tasks, proactively identify risks and opportunities, and take ownership of process optimisation initiatives while upholding high standards of quality, efficiency, and compliance.
Your new department You will join the Nonclinical Submission Support Team, a small team of 3-4 employees responsible for delivering submission-ready nonclinical packages across the entire pipeline. The team plays a critical role in ensuring high-quality, compliant, and timely submissions to health authorities across global markets and is part of Research Operations & Compliance (ROC). In ROC, we provide quality, compliance, and operational business support that enables research and nonclinical development to focus on scientific innovation.
Our department consists of 18 highly engaged employees with diverse expertise and a shared mission: to enable scientists to focus on science while safeguarding our licence to operate. Our culture is one of high empowerment and trust, with a strong focus on driving change ultimately for the benefit of the patient. Your skills and qualifications You understand how a regulatory submission package is structured and what is required to make it complete and compliant.
You are comfortable coordinating complex documentation across functions, systems and geographical locations, and you bring a pragmatic approach to quality and problem-solving. To succeed in this role, we expect you to have: A bachelor’s or master’s degree in pharmacy, science or another relevant field. An advanced degree is an advantage.
At least 5 years of experience with regulatory submissions in the pharmaceutical industry or a comparable environment. Experience working with Document Management Systems (Veeva Vault), combined with strong Microsoft 365 skills, particularly Microsoft Word and Excel. Knowledge and understanding of global regulatory requirements, including EMA, FDA, ICH, and other applicable electronic documentation requirements.
Experience with process development and optimisation. Professional proficiency in written and spoken English, strong stakeholder-management skills and the ability to work independently, proactively and collaboratively. Experience with document migration, business integrations and knowledge of nonclinical documentation and Good Laboratory Practice (GLP) would be an advantage.
You are adaptable, accountable and motivated by delivering high-quality work in a timely and compliant manner. 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: For this role, the Annual Base Salary ranges from 651,000 to 956,900 DKK (DK), 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 here .
Contact: Josephine Hebsgaard, Director of Research Operations & Compliance, +4530790806. Deadline: 25th September 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.