Senior Regulatory Professional for Rare Bleeding Disorders area (

Are you able to cut through complexity and drive regulatory strategies for high impact projects? Would you like to work together with experts across multiple functions in a global environment? Do you want to be part of an exciting area where engaged people are committed to bring innova-tive treatment to patients across the globe?

Then we invite you to join Novo Nordisk as a Senior Regulatory Professional in Regulatory Affairs (RA). Our people possess a distinctive blend of scientific expertise, a patient-centric approach, and the capability to navigate various agendas and stakeholders. Take the next step by submitting your application today!

The position

We have 12- months temporary position within the “Rare Bleeding Disorders” therapeutic area as a Senior Regulatory Professional in a project with focus on late-stage clinical development ap-proaching regulatory submission.

In this role, you will support the development of regulatory strategies and execute various regula-tory tasks within cross-functional project teams. This will involve interacting with a diverse array of stakeholders throughout the process.

Your key responsibilities will include:

Contributing to global regulatory strategies and tactics by providing your knowledge via analysing regulatory opportunities and risks

Ensuring that the project strategy is implemented in the planned global submission roll-out and leading the launch planning process from a regulatory perspective

Developing regulatory documentation for submission to Health Authorities, e.g. meeting packages, paediatric plans and MAAs/NDAs/BLAs

Collaborating with project management, medical and non-medical specialists, statisti-cians, and medical writers.

Your contribution in this position will be crucial for delivering cutting-edge solutions that prioritize patients, fostering innovation, and achieving excellence. This necessitates a strong sense of teamwork, communication skills, collaboration, and expertise among your colleagues, as well as a deep commitment to sharing knowledge. Prepare to be immersed in an environment of talent-ed individuals who embrace cooperation, within a culture that empowers and values humility.

Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office in Denmark and on-site work in Søborg, Denmark where our team is based.

Qualifications

For this role, we are looking to connect with candidates who have:

An academic degree in life science or similar, which may be supplemented with a PhD degree

Solid and hands-on regulatory and/or drug development experience

Good pharmaceutical industry knowledge

Proficiency in interacting with regulatory authorities on an international scale would be an advantage

Strong IT/digital skills

Ability to communicate in fluent English (both written and spoken)

As a person, you thrive in a fast-paced work environment characterized by ambiguity. You bring a can-do spirit and a healthy sense of humour 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 are a skilled communicator who can collaborate as a strategic business partner at any organizational level.

About the department

The department is responsible for Rare Bleeding Disorders with projects in early and late-stage development going into the submission phase. The department consists of 13 dedicated and highly engaged employees of 7 different nationalities with diverse backgrounds and expe-riences. We work in a flexible set-up where trust and openness, sparring, challenge, and knowledge sharing foster an inclusive and innovative culture we all enjoy being part of.

Working at Novo Nordisk

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.

Contact

For further information, please contact Jane Møll Pedersen at +45 30753759.

Deadline

18 May 2025

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

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.