Senior Regulatory Professional - Publishing DK, Regulatory, Quality & Clinical Reporting

This role offers a unique opportunity to become part of an exciting environment where engaged people work with new technologies and diverse therapeutic areas to bring innovative medicines to patients. As the Senior Regulatory Professional in Publishing DK, Regulatory, Quality & Clinical Reporting (RQ&C) you will be at the forefront of ensuring compliant regulatory eCTD submissions to the Health Authorities.

Your new role

As Senior Regulatory Professional in Publishing DK you will drive activities that enables us to manage major global eCTD submission projects and ensure compliant eCTD submissions of a vast variety of post approval changes. Furthermore, you will support the implementation of new eCTD requirements including internal onboarding of new eCTD submission countries as well as contribute on making improvements to the way we work and our processes.

Your main responsibilities include:

• Manage and publish major global eCTD submission projects in cooperation with the regulatory teams, the report publishing units, and the global regulatory publishing team.
• Manage and publish regulatory NDA roll-out submissions and post-approval changes in eCTD format
• Provide guidance and support to project teams, stakeholders and colleagues, ensuring adherence to eCTD standards and best practices
• Contribute on improving the Regulatory electronic submission and publishing processes

Your new department

You will have the unique opportunity to be part of RQ&C Operations where you will join the Publishing DK department that plays a key role in ensuring compliant electronic regulatory submissions to Health Authorities. RQ&C Operations is an exciting area involved across the value chain of Novo Nordisk. We are responsible for driving and streamlining the submission and labelling operations to obtain best in class labels as well as effective and compliant regulatory submissions for current and future products, responsive to the worldwide business needs of Novo Nordisk. You will work in a fast-paced environment where it is important to be able to manage deadlines in a complex context of international communication across time zones, cultures, and circumstances. The atmosphere in the team is informal, and good humour is always welcome.

Your skills and qualifications

The ideal candidate has:

• Master of Science in a relevant field, such as pharmacy, science, or equivalent.
• Minimum 5 years of experience in the pharmaceutical industry, preferably within Regulatory Operations or Regulatory Affairs
• Strong interest in and knowledge about eCTD publishing processes and document management
• Good understanding of the evolving Regulatory eSubmission standards and environment
• Good project management skills and strong in setting direction and making impact
• Experience working with Veeva RIM or other regulatory IT platforms is an advantage.
• High proficiency in English

As a person you are a team player who maintains customer focus even when delivering submissions under sometimes tough circumstances. You are open to flexible working hours to accommodate other time zones when needed. You are well organised, analytical with solid problem-solving capabilities, just as you show a winning and positive attitude, and never lose your strategic focus. You can keep your spirits high even under pressure, and as a skilled communicator you can cooperate at any organisational level.

Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination, and a constant curiosity. For over 100 years, this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect, and a willingness to go beyond what we know delivers extraordinary results.

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.

More Information
For further information, please contact Associate Director, Robert Navy Lund, at rene@novonordisk.com.

Deadline

10 January 2026.

To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.