Global Regulatory Lead in CVD/CKD 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 innovative treatment to patients across the globe?

Then we invite you to join Novo Nordisk as a Global Regulatory Lead 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 a vacant position within the “Cardiovascular & Chronic Kidney Diseases” therapeutic area.  As a Global Regulatory Lead, you will lead the development of regulatory strategies and executing various regulatory tasks within cross-functional project teams. This will involve interacting with a diverse array of stakeholders throughout the process.

Your key responsibilities will include:

• Drive regulatory strategies and clinical regulatory activities for the assigned early to mid-stage development projects. 
• You will be a member of cross-functional project teams, and as such, interact with a variety of stakeholders from different departments in Novo Nordisk.
• You will as Global Regulatory Lead be accountable for bringing regulatory strategic leadership and innovation to the project and proactively contribute to project team decisions e.g. by forming global regulatory strategies, leading health authority interactions, providing input to clinical and non-clinical development, and coordinating and planning all regulatory activities.
• You will lead the regulatory activities including leading the RA Matrix team for the assigned projects to ensure timely and high-quality regulatory deliverables to the global project teams.
• You will work closely with other colleagues, ensure knowledge sharing within- and across projects, and provide sparring and mentoring to others.
• You will report to the Head of the RA CVD/CKD team and will take active part in department related activities, including improvement projects across Global RA. In addition, you will work in a fast-paced environment with tight deadlines where no two days are alike, and you will be supported by highly skilled and committed colleagues.

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

Qualifications

To succeed in this role, we expect you to have:

• Your background covers a master’s degree within life sciences with 7+ years of relevant experience and/or PhD with 5+ years of relevant working experience, within pharmaceutical/biotech company, including global experience working in a company headquarters setting.
• You have solid regulatory experience including health authority’s interactions and an all-round understanding of regulatory requirements for drug development.
• You are driven by science and innovation, can understand complex scientific issues, and will be able to bring them into a regulatory context and display a strategic mindset.
• You are well organized and have solid project management skills and problem-solving capabilities.
• Finally, you are a good communicator and are comfortable using your fluent written and spoken English daily.

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 – even when pressure is on. You build effective working relations and have a flexible mindset.  You like to experiment and show curiosity and creativity and can suggest unordinary solutions.

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

RA Cardiovascular & Chronic Kidney Disease is responsible for contributing to the development of different products and projects within the cardio-vascular and chronic kidney diseases field working with a pipeline including early and late phase projects that investigate a variety of different modalities and technologies including monoclonal antibodies, RNA based products and oral administered compounds.

Our department is made up of 16 dedicated and highly engaged employees with diverse background and experience. We are looking for a Global Regulatory Lead who will focus on early to mid-stage clinical development assets.

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 Poul-Martin Haahr at +45 30754082.

Deadline

12 February 2025. We will review the applications on an ongoing basis, so we encourage you to apply as soon as possible.

We are looking for several similar profiles at Novo Nordisk now. Therefore, Hiring Managers from different teams might also look at your application.

To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV.

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.