Novo Nordisk A/S
Gladsaxe, 1 stilling
- Regulatory Affairs
- Denmark - Søborg
Join a fast-changing environment where engaged people do their best every day to obtain and maintain market authorisations worldwide for all Novo Nordisk medicine across the globe. Our people have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting place to work – but also quite challenging. Are you up for the challenge?
About the department
RA Oral GLP-1 & Early Diabetes Projects are responsible for development projects within treatment of diabetes and diabetic complications. We are six dedicated and highly engaged employees working in the department.
We work as an integrated part of the global development project teams and cross-functional sub-teams. We are responsible for the regulatory strategy 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 combined with regulatory experience to support our activities related to clinical trial submissions and approvals and interactions with Health Authorities.
The job
As regulatory professional you will be part of a regulatory team and be responsible for regulatory (clinical) activities for an oral GLP-1 project in development phase 3. You will be responsible for submission and approval of clinical trial applications, for driving and coordinating preparation of meeting packages to Health Authorities and for regulatory submissions. You will be a member of clinical trial study groups, providing regulatory input to clinical protocols and reports. You will interact with medical specialists, statisticians and medical writers.
You will report to the Director of Oral GLP-1 & Early Diabetes Projects and take active part in department related activities, including improvement projects across RA.
Qualifications
You hold a relevant university degree, e.g. MSc, preferably complemented by a PhD and have 3-5 years of relevant 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.
You are a strong team player, but you are also able to work independently and find new solutions to the challenges you meet. Your communication skills are excellent and you are fluent in English both in writing and in speech.
At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment.
Contact
For further information about this position or about Novo Nordisk Regulatory Affairs, please don’t hesitate to contact Vibeke Hatorp on + 45 3075 5697.
Deadline
27 October 2015.
