Senior Regulatory Professional - RA New Generation Insulin Projects

Novo Nordisk A/S

Ph.d. & forskning




Ørestad, Capital Region of Denmark, DK

Join Regulatory Affairs 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 are regulatory responsible for the clinical new generation insulin development projects as well as the clinical Life Cycle Management activities for marketed long-acting (Tresiba®), fixed combination (Ryzodeg®, Xultophy®), and fast-acting (Fiasp®) insulin products. We are 16 dedicated and highly engaged employees working in the department.

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 label development, 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 Senior Regulatory Professional with a strong scientific background and a genuine interest in being part of the future within New Generation Insulin Projects.

The job
As a Senior Regulatory Professional, you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines.

You will be a member of cross functional project teams including study groups and submission teams, and as such, interact with a variety of stakeholders from different departments and affiliates in Novo Nordisk. You will participate in the development of regulatory documentation for submission to Health Authorities, including briefing packages for meetings with Health Authorities, clinical trial applications, clinical trial protocols and reports and regulatory files for marketing authorisation. Furthermore, you will be expected to provide regulatory input, be proactive, challenge the discussions and contribute to project team decisions. You will among others interact with medical and non-clinical specialists, statisticians and medical writers. You will also have the opportunity to contribute to projects for the improvement and maintenance of regulatory processes across the organisation.

We expect you to have a master degree in life science (preferably complemented by a PhD) and 4-7 years of experience from the pharma industry (e.g. regulatory sciences, clinical and non-clinical drug development, device development, medical writing, clinical trial management). As a person you thrive in a busy environment; bring a can-do spirit and a healthy sense of humour to your work. You are a flexible and change-oriented person who focus on opportunities rather than limitations in challenging situations.

Working at Novo Nordisk
At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.

For further information, please contact Louise Buchholt Johansen on +45 3079 13 81.

Deadline 28 January 2020. Relevant candidates will be invited for interview also before deadline.

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

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Ansøgningsfrist d. 28.01.2020
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Ph.d. & forskning
Medicinal & Sundhed
Forskning & Udvikling
Medicinal & Sundhed

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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Logo: Novo Nordisk A/S
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