Regulatory Professional - Long-acting Insulin Projects

• 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 Long-acting InsulinsProjects are responsible for the clinical long-acting insulin development projects as well as the clinical Life Cycle Management activities for marketed long-acting insulin products. We are nine 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 Regulatory Professional with a scientific background and a genuine interest in being part of the future within Long-acting Insulin Projects.

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 submission teams, and as such, interact with a variety of stakeholders from different departments 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 file 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.

Qualifications

We expect you to have a Master of Science (life sciences) and/or PhD with some relevant working experience (3-4 years). As a person you thrive in a busy environment; bring a 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 Louise Buchholt Johansen on +45 30 79 13 81.

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.