Global Regulatory Lead in CVD/CKD area

Category: Reg Affairs & Safety Pharmacovigilance

Location: Søborg, Capital Region of Denmark, DK

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 bringing 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

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 execute 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.
• Be a member of cross-functional project teams, interacting with various stakeholders from different departments in Novo Nordisk.
• Accountable for bringing regulatory strategic leadership and innovation to the project and proactively contribute to project team decisions by forming global regulatory strategies, leading health authority interactions, providing input to clinical and non-clinical development, and coordinating and planning all regulatory activities.
• 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.
• Work closely with colleagues, ensure knowledge sharing within and across projects, and provide sparring and mentoring to others.
• Report to the Head of the RA CVD/CKD team and take an active part in department-related activities, including improvement projects across Global RA.

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

• A master's degree within life sciences with 7+ years of relevant experience and/or a PhD with 5+ years of relevant working experience within a pharmaceutical/biotech company, including global experience working in a company headquarters setting.
• Solid regulatory experience including health authority interactions and a comprehensive understanding of regulatory requirements for drug development.
• A drive for science and innovation, the ability to understand complex scientific issues, and to bring them into a regulatory context while displaying a strategic mindset.
• Strong organizational and project management skills with problem-solving capabilities.
• Excellent communication skills and comfort using 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 under pressure. You build effective working relations and have a flexible mindset. You enjoy experimenting and show curiosity and creativity, suggesting innovative solutions.

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

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

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.

For further information, please contact Poul-Martin Haahr at +45 30754082.

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 the communities we operate in. Together, we're life-changing.