Regulatory Professional - biopharm

Novo Nordisk A/S





Søborg, Capital Region of Denmark, DK

Join Regulatory Affairs and become part of an exciting environment where engaged people are committed gaining 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.

We are currently looking for a Regulatory Professional with a scientific background and a genuine interest in being part of the future within Rare Endocrine Disorders projects.

About the department
RA Rare Endocrine Disorders Projects are responsible for the regulatory deliverable for clinical projects and life cycle managements of approved products. We are 8 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.

The job
As a regulatory professional in RA Rare Endocrine Disorders, you will be required to drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines.

You will be a member of cross functional project teams responsible for deliverables during lifecycle management. You will interact with a variety of stakeholders from different departments and worldwide affiliates in Novo Nordisk. You will participate in the development of regulatory documentation to Health Authorities, including safety documents, variation applications, briefing packages for meetings with Health Authorities, clinical trial applications and clinical trial protocols.

Other responsibilities include ensuring that regulatory commitments are met, promotional materials are aligned with our labelling and that Investigator initiated studies are in accordance with the regulatory strategy. You are expected to provide regulatory input, be proactive and challenge and contribute to project team decisions. You will also have the opportunity to contribute to projects for the improvement and maintenance of regulatory processes.

Qualifications We expect you to have a university degree in science have 2-4 years of experience from the pharma industry, preferably within Regulatory Affairs.

As a person you thrive in a busy environment; bring can-do spirit and a healthy sense of humor to your work – even when the pressure is on. You are a flexible and change-oriented person who focuses on opportunities rather than limitations in challenging situations.

For further information, please contact Marianne Bork Samuelsen +45 3079 6941

28th January 2020

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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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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