Novo Nordisk A/S
Gladsaxe, 1 stilling
- Regulatory Affairs
- Denmark - Søborg
Would you like to be part of Novo Nordisk Regulatory Affairs and part of “can-do”, “no-fuss” department located in Søborg, Denmark? If yes, then we are seeking a Senior Regulatory Professional for the semaglutide project.
About the department
Regulatory Affairs is an area within Global Research and Development, responsible for obtaining and maintaining marketing authorisations worldwide. This includes interaction with Health Authorities in connection with planning of meetings, submission of clinical trial applications, submission and maintenance of marketing authorisation applications. You will work together with a highly skilled and motivated team responsible for ensuring the marketing authorisation of a new product for type 2 diabetes, semaglutide.
The job
As Senior Regulatory Professional you will coordinate the regulatory clinical activities needed to ensure approval of a late-stage diabetes project, together with a regulatory project team of other regulatory professionals as well as associates.
No two work days will be alike! Tight deadlines, cross-departmental collaboration and the challenges of international communication will be part of your busy workday.
Your workday will consist of coordinating the clinical aspects of the regulatory affairs discipline: global clinical trial applications, labelling, and global submission activities. You will work together with our many internal stakeholders that need support with regulatory knowledge, such as medical, clinical, safety, and marketing departments. You will be expected to make an impact, ask questions and challenge the status quo if that’s what it takes.
You will ensure regulatory deliverables according to agreed time, cost and quality. You will assume the role of the proactive advisor regarding regulatory opportunities and risks related to clinical activities.
Qualifications
We expect you to have a university degree in science (Master’s degree or PhD) and long-term experience working in regulatory affairs or from working within a clinical/medical area where you have contributed to regulatory filings. You should have a solid clinical knowledge as well as experience with global submissions.
As a person, you thrive working with both operational as well as more strategic tasks. You bring a can-do spirit and a healthy sense of humour to your work – even under pressure. You are a dedicated team player, but you also enjoy working independently and finding new solutions to the challenges you meet. You are a skilled communicator who is comfortable speaking and writing English.
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 Katarina Jelic Maiboe on +45 3079 0235.
Deadline
8 November 2015.
