In Novo Nordisk Regulatory Affairs my work has an impact, I can drive change, develop and grow my career

In Novo Nordisk Regulatory Affairs we are committed to being one step ahead for our patients and for our business. The scope of our work spans across the entire research and development value chain. And therefore, we feel we are like the glue that connects research to commercial access. That goes from the earliest stages of drug development and research, and all the way to securing and maintaining commercial licenses for our life-changing treatments.

 We strive to constantly innovate and develop patient-centric solutions beyond the drug, including diagnostics, digital health, and best-in-class devices among many others. We build, prepare, and execute robust regulatory strategies and expand the life cycle of approved products to secure our licenses to operate. All for the purpose of driving change and giving people access to best-in-class, life-changing treatments – faster than ever. And that’s why we daily strive to be a valued, strategic business partner across the value chain.

We have a very collaborative, knowledge-sharing, and inclusive culture in Regulatory Affairs. It fits our vibrant, informal, and curious atmosphere perfectly. And combined with our critically analytical mindsets, intelligent use of technology, and our bold, innovative thinking, we achieve a great overview and a deep understanding of every step of the entire process. Our approach, culture and ways of working empower us to develop and grow as individuals and to improve and optimise our processes as a team – making our work and efforts valuable and impactful to both Novo Nordisk and the lives of our patients worldwide. 

  • In Regulatory Affairs Therapeutic Areas (TAs) we are responsible for leading the regulatory science and designing the global regulatory strategies to advance projects from early stages of research and development to worldwide submission and approval of initial Marketing Authorisation applications. These strategies also entail, designing and planning proactively the life cycle management of our products. We work as an integrated part of the Novo Nordisk Development organisation and play a key role throughout the value chain from candidate selection to the deregistration via. the cross-functional teams.
  • We are responsible for the development, implementation and execution of global regulatory strategies and regulatory operational activities in alignment with the global project development plan fully integrating pivotal elements of data, digital health, devices and diagnostics- all driving towards bringing best in class and most innovative solutions to our patients globally . We drive label development, health authority interactions and regulatory submissions, hereunder initial marketing authorisation applications, paediatric plans, and clinical trial applications as well as lifecycle management activities in close collaboration with our affiliates and global stakeholders

  • In RA CMC & Device, we are facilitating dialogues between our project teams and health authorities around the globe with focus on our existing/innovative CMC and device solutions aiming to provide medicinal products with not just high quality, efficacy and safety, but also with best patients usability.
  • CMC solutions are highly diverse due to the complex manufacturing processes depending on the nature and types of products, which are currently expanding according to corporate product portfolio strategy.  At this point, we are working with diverse therapeutic solutions including peptide drugs, biologics, cell therapy products, gene therapy products, siRNA, small molecules, etc., each being administered to our patients with suitable devices.
  • In addition, modern manufacturing and analytical technologies with potential of integrated AI solutions enable ever increasing speed on continuous improvement and innovative CMC/device solutions for both development projects and marketed products. As a RA colleague in CMC & Device, our job is first of all, to be a strategic partner to the projects, by understanding the existing/innovative CMC solutions, identifying potential regulatory risks by studying relevant regulations, and providing scenarios for mitigation; Secondly, through submission of registration documentation to HA and/or facilitating interaction meetings with the HA, etc., on one way, we convince the Health authorities that with our CMC solutions, we are in full control of our manufacturing process and we are delivering high-quality products complying to the relevant regulations, and meanwhile, channel the feedback/current thinking from the Health authorities into the projects.

  • The area RA Digital Health & IVD support the NovoNordisk 5D strategy by enabling the development of Digital Health and Diagnostic Products to create fully integrated solutions for our patients beyond the drug. We are a strategic partner across the product life cycle and responsible for providing regulatory advice, drive submission of connected devices and SaMD (Software as Medical Device) globally in close collaboration with our affiliate colleagues. Additionally we are a key partner in supporting strategic NovoNordisk digital and diagnostic partnerships and development of Software as a Services (SaaS) products.
  • We play a key part of the project team from the very beginning of development of a new digital or diagnostic tool. By developing the regulatory strategy and driving authority interactions we are a strategic partner to the project director and sit on the core project teams. As a team of 15 employees we work closely together across experience level in a matrix setting. This provides great opportunity to variety in the role and personal development. Advocacy and external collaboration is also key to our success. We are members of several industry working groups and have a dedicated partner in our policy and intelligence team. If you have interest for digital health solutions, a strategic mindset, strong stakeholder management skills and love to work in the interface of continuously developing regulations and engineering techniques, you should come join us.

  • In RA Labelling we secure key deliverables within development of printed packaging materials for our entire product portfolio. The responsibility includes colour and graphic solutions which are critical steps towards timely submissions and approvals and which safeguards product differentiation for our patients. We are key in the overlap from approval to launch related to printed packaging material readiness and we are accountable to life-cycle-management of all our products world-wide.
  • We work in close collaboration with the entire value chain including all affiliates, supply chain planning, our manufacturing sites, Quality and many more stakeholders. We feel very close to our patients in daily work as the printed packaging material, is the first touch-point they have when picked up from the pharmacy.

  • In RA Digitalisation we have gathered all Regulatory Affairs transformation projects under one portfolio. We design future processes, we engage the organisation for change, and ensure that our organisational set-up is fit for the future. We collaborate closely with our IT organisation in the SAFe/Agile framework connecting with stakeholders across the global Novo Nordisk organisation.
  • The Novo Nordisk growing product portfolio demands that we work leaner and faster. RA Digitalisation helps the organisation to get there by simplifying how we work and collaborate.
  • This means taking advantage of available digital solutions to create a unified IT landscape, and at the same time, we develop brand new technical solutions that will both impact how regulatory authorities think about regulatory submissions and bring better and more useful solutions to patients faster and in a higher quality.

In our unit we work with all aspects of regulatory affairs, and we are heavily involved throughout the entire lifecycle of a product. Our work is essential to keep bringing innovative, patient-centric, and best-in-class solutions to our patients – also including diagnostics and digital health. That calls for team spirit, collaborative minds, skilled colleagues, and a great focus on knowledge-sharing. So, look forward to being surrounded by talented, cooperative, and embracing teammates in a strong and empowering culture filled with humble people

To us, learning and development are key to life-long employability and wellbeing. Our philosophy is clear: When you thrive, and are properly challenged in your position and job, you are the best and most valuable colleague. Being part of an organisation that works as a strategic business partner across different parts of a product’s life cycle, you have exciting opportunities in both our unit and across the company. You sit in the driver’s seat of your career – we are the door openers.

The ‘what if’-question is mandatory in Regulatory Affairs. We ask that question a million times a day – as part of our creative and innovative ways of thinking. To us, it’s both natural and a must when we create regulatory strategies, as there is never one right solution. Therefore, we do a lot of regulatory risk analysis, build a lot of scenarios, and dare to point out weaknesses and uncertainties. That’s why we never bring only one solution or recommendation to our stakeholders’ table.

We have a very open-minded, collaborative, inclusive environment, and we welcome all questions. Also, the ones that challenge the way we think, as they often lead to new angles and great answers. We are team players by heart. We cherish our ideation and all the great opportunities we have to learn from each other daily. We speak our minds, we listen, we are attentive – and we have fun.

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