Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring rapid regulatory approval in all our markets. Regulatory Affairs is a fast-changing field, and the dedicated employees in our unit need both keen negotiating skills and scientific insight to serve as Novo Nordisk’s advocates around the world – and make a meaningful difference to our business.
We are currently looking for a regulatory professional with an interest in the Haemophilia area to join our team of specialists working with the turoctocog alfa project (rFVIII).
In the area we are 30 people working with six haemophilia projects ranging from early to late stage development. We are currently looking for a Regulatory Professional with a science background and experience in worldwide drug development to join our team in the RA Haemophilia New Projects department in the project house in Søborg. The ideal candidate for this position has a strong knowledge of the requirements for the development of biologic products worldwide with a focus on the quality part.
Challenges
In Regulatory Affairs, you’ll work in a fast-paced environment where no two days are alike. Tight deadlines, cross-departmental collaboration, project management and the challenges of international communication will be part of your busy workday. You’ll be expected to make an impact and to ask questions and challenge the status quo if that’s what it takes.
The haemophilia projects offers its own special challenges, and you can expect to spend a considerable amount of time working with the submission for marketing authorisation worldwide with focus on areas outside EU and USA. You’ll be managing the compiling and preparation of the submissions, and be involved in all aspect of the regulatory affairs descipline within these areas, including interactions with health authorities.
Qualifications
We expect you to have a university degree in science and documented professional experience working with regulatory affairs and the pharma industry. It is important that you have experience with preparation of submissions worldwide in general and particularly the quality part of the application.
As a person, you thrive in busy environments and bring a can-do spirit and a healthy sense of humour to your work – even when the pressure is on. You’re a strong team player, but you also enjoy working independently. We also expect you to challenge the status quo and actively contribute to finding new solutions to the challenges you meet. You’re organised, a good planner and a proactive problem-solver, who are able to collaborate with a lot of stakeholders. You’re also a skilled communicator who is comfortable speaking and writing in English.
Contact
For further information, please contact Frank Bringstrup at +45 3075 8208 or Lene Garde Sommer at +45 3075 9762.
