Senior Regulatory Professional

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Research & Development

RA Rare Bleeding Disorders - A lifetime experience within rare disease drug development 

Join Global Regulatory Affairs (GRA) 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. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes GRA a truly interesting and challenging place to work. 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 Senior Regulatory Professional, you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines.

Your main tasks will be focused on:

• 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 team clinical trial team responsible for clinical trial applications, amendments and clinical trial reports.
• 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.

Specifically, for this job you will get the opportunity to be part of a team who right now are in phase 3 with a rare disease and soon will be facing a very exciting period of authority interactions and planning for obtaining the regulatory approval.

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

Your new department
RA Rare Bleeding Disorders department is part of Global Regulatory Affairs and situated in Søborg, Denmark. 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 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. We have a strong collaboration with our stakeholders in affiliates and work in global regulatory matrix teams with colleagues from many other departments.

Your skills and qualifications

We're seeking candidates who fulfil the following prerequisites:

• We expect you to have a master’s degree in life science.
• You have 4-5 years of regulatory or drug development experience.
• It is an advantage if you have a background within Clinical Operation, Medical Writing, or Research. 
• You are a skilled communicator who can collaborate as a strategic business partner at any organisational level.
• Finally, you are comfortable using your fluent written and spoken English.

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.

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.

More information

For further information, please contact Senior Director, Jane Møll Pedersen, at +45 30 75 37 59.

Deadline

1st of December 2025.

Applications are reviewed on an ongoing basis, and the position may be closed before the deadline.

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.