Novo Nordisk A/S
Gladsaxe, 1 stilling
- Regulatory Affairs
- Denmark - Søborg
Join Regulatory Affairs (RA) and become part of a fast-changing environment where engaged people do their best every day to get Novo Nordisk’s medicines approved 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 place to work – but also quite challenging.
We are currently looking for a Senior Regulatory Project Manager, with a strong background in early development, to join the RA Early Haemophilia Unit.
About the department
In the RA Biopharm area we are responsible for all the clinical regulatory activities for Haemophilia, Growth Hormone and Hormone Replacement Therapy (HRT). In the early haemophilia unit we focus on development projects before Phase 3. We are organised in smaller product teams within the department, however we work in a flexible manner according to work load. You will work in a fast paced environment with tight deadlines, and you will be supported by friendly colleagues with a good sense of humour.
The job
You will be the global regulatory lead for a number of pre-Phase 3 haemophilia projects. You will give expert, strategic regulatory input to the project development plan, covering non-clinical, quality, clinical and regulatory aspects. You will work together with the other team members in the early haemophilia unit and our stakeholders outside regulatory to set the stratigic regulatory direction for the projects.
Qualifications
You will have 7-10 years years experieince in regulatory affairs with a strong track record in early drug development. You will have extensive experience with early clinical development e.g. dose-finding, POC as well as a solid knowledge of expedited regulatory pathways, orphan drugs and biologics.
On a personal level, you are a fast-learner, creative and enjoy investigating and finding different solutions to a wide range of challenges. You are self-motivated and interested in sharing your knowledge with others to make the early haemophilia unit a centre of regulatory excellence.
At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes and haemophilia. 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 Alice Troy on +45 3075 4026.
Deadline
24 December 2015.
