Senior Regulatory Professional in RA Rare Bleeding and Hematorenal Disorders

Join Regulatory Affairs and become part of an exciting environment where engaged people are committed to gain approval of Novo Nordisk’s medicines by regulatory authorities across the globe. This position offers a lifetime experience in terms of drug development - a culmination of many years of research and development, the current focus is the creation of a regulatory file with the purpose of obtaining marketing authorisation on a global scale and serve the patients with better treatments.

Your new role 

As a person you thrive in a fast-paced work environment with unfamiliar situations. You bring a can-do spirit and a healthy sense of humor to your work. You are a flexible and change-oriented person who likes to experiment and sees opportunities rather than limitations in challenging situations. It is important for you to feel that you are part of a team and an active contributor to the success of the team:

You will be a member of cross functional project and submission teams, and as such, interact with a variety of stakeholders from different departments in Novo Nordisk.

You will be part of the clinical trial team responsible for clinical trial applications, amendments and clinical trial reports.

Depending on phase of the project, you will be responsible for the development of regulatory documentation for submission to health authorities, including information packages for authority meetings, response packages for health authorities, and regulatory file for marketing authorisation.

Furthermore, you will be expected to contribute to the global regulatory strategies and tactics, be proactive and bold, challenge the discussions and contribute to project team decisions. You will among others interact with project management, medical and non-clinical specialists, statisticians and medical writers.

You will report to the Senior Director of RA Rare Bleeding Disorders and take active part in department related activities, including improvement projects across RA.

Your new department

RA Rare Bleeding Disorders department is part of Regulatory Affairs and situated in Søborg, Denmark. We are contributing to the development of different products and projects within Rare Bleeding Disorders with a pipeline including a variety of different modalities and technologies including gene therapy.

We are a department with 14 dedicated and highly engaged employees of 8 different nationalities with diverse backgrounds and experiences. We work in a flexible set-up where trust & openness, sparring, challenge and knowledge sharing fosters an inclusive and innovative culture we all enjoy being part of. We work as an integrated part of the global development, research project teams and cross-functional sub-teams. We are responsible for the regulatory strategies and provide regulatory expertise and tactics to the product development plan. We drive product labelling, Health Authority interactions and clinical trial applications.

Your skills and qualifications

As a Senior Regulatory Professional, you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines.

• We expect you to have a university degree in life science and have 4-5 years of regulatory or drug development experience.
• You are a skilled communicator who can collaborate as a strategic business partner at any organizational level.
• You are proficient in common IT tools and systems relevant to regulatory affairs, including Microsoft Office and electronic document management platforms and have the ability to quickly learn and navigate new digital solutions and regulatory databases to support submission processes and cross-functional collaboration.

While flexible work is valued, the job requires physical presence to enable effective discussion, knowledge sharing, and strong team connections. Finally, you are comfortable using your fluent written and spoken English.

Working at Novo Nordisk

Every day we seek solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, rare determination, and 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.

Salary: For this role, the Annual Base Salary ranges from 651,100 DKK to 956,900 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 here.

Contact

For further information, please contact Director Jane Møll Pedersen at +45 3075 3759 .

Deadline

Deadline 15h May, 2026. 

Applications will be evaluated continuously when received and candidates may be called for interview before the deadline.

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