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Senior Regulatory Professional (Denmark, Søborg)

Novo Nordisk A/S

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Søborg, Denmark


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Are you keen to make a difference for people living with diabetes?

Join Regulatory Affairs (RA) 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 Regulatory Affairs a truly interesting and challenging place to work.

About the department
RA New Generation Insulin Projects is part of Global Regulatory Affairs and situated in Søborg, Denmark. We are contributing to the development of innovative insulin treatments for people living with diabetes:

  • once-weekly basal insulin (icodec) and once-weekly combination of insulin icodec and once-weekly injectable GLP-1 semaglutide (IcoSema)
  • glucose-sensitive and cardio-protective insulins, new oral delivery devices and insulin for pump use
  • clinical strategies for marketed insulin projects including projects under NN commitment to ‘provide access to affordable care for vulnerable patients’

We are a department with 14 dedicated and highly engaged employees with diverse background and experience. We work in a flexible set-up with small, overlapping, self-managed teams where trust & openness, sparring & challenge – and knowledge sharing fosters an inclusive and innovative culture we all enjoy being part of.

We work as an integrated part of the global development and research project teams and cross-functional sub-teams. 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 affiliates and work in global regulatory teams.

We are currently looking for a new colleague who has a genuine interest continuing to develop and provide innovative insulin treatments to patients worldwide.

The job
As a Senior Regulatory Professional, you will be responsible for a wide range of regulatory phase 3 activities for once-weekly insulin icodec. Depending on qualifications and interests you may also contribute to early development projects. You will drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines.

You will play a key role in project planning and project execution, provide regulatory input for the project strategy, interact with internal and external stakeholders (e.g. Health Authorities) and represent Regulatory Affairs in project teams.

Furthermore, you will be responsible for submission and approval of clinical trial applications, for driving and coordinating preparation of meeting packages to Health Authorities, conducting Health Authority interactions and for regulatory submissions and approvals. Interactions with marketing and medical specialists, researchers and regulators are essential for your success. All in all, you will have a large responsibility and you will have a lot of influence and impact on the way we achieve and sustain best in class approvals, to make a difference for patients.

You will report to the Director of RA New Generation Insulin Projects and take active part in department related activities, including improvement projects across RA.

We expect you to have a university degree in life science (may be complemented by a PhD) and have 5-7 years of regulatory or drug development experience.

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 the success of the team. You are a skilled communicator who can collaborate as a strategic business partner at any organizational level. Finally, you are comfortable using your fluent written and spoken English on a daily basis.

Working at Novo Nordisk
At Novo Nordisk, we use our skills, dedication and ambition to help people with chronic diseases such as Diabetes, Obesity, NASH, CVD, Rare Endocrine Disorders as well as Rare Blood Disorders. We offer the chance to be part of a truly global and highly diverse workplace, where passion and engagement are met with opportunities for professional and personal development.

For further information, please contact Louise Buchholt Johansen on +45 3079 1381

Deadline 9 May 2021


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Novo Nordisk A/S - hurtigt overblik

Novo Nordisk A/S
Novo Nordisk A/S
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity.

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