Regulatory Professional - GLP-1 Diabetes

• Regulatory
• Søborg

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.

About the department
RA GLP-1 Diabetes are responsible regulatory activities for our key GLP-1 products that help patients with Type 2 diabetes and at the same time reduce the risk of cardiovascular disease. We work together with our stakeholders to ensure that labelling reflects strong scientific data and to continue to develop new GLP-1 based products that bring even better treatment to patients. We are seven dedicated and engaged employees working in the department.

We work as an integrated part of the global research and development project and commercial teams. We are responsible for the regulatory strategy and provide regulatory expertise and tactics to the product development plan throughout the entire product lifecycle. We drive the global regulatory applications, label expansion, 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 Regulatory Professional with a is looking to take ownership of regulatory process across the all stages of the product lifecycle.

The job
As a regulatory professional 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 including study groups and 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.

As a person you thrive in a busy environment; bring can-do spirit and a healthy sense of humour 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.

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.

Contact

For further information, please contact David Truloff on +45 30790499.

Deadline

28. July 2019

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.