Regulatory Affairs
Regulatory Submission Professional
Summary
Plans and coordinates Clinical Trial Application distributions worldwide and prepares, manages and submits EU applications through CTIS. The role also supports process development and collaboration across submission teams.
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Opportunity summary
Pay: 570,200–838,100 DKK per year. Country: Denmark. . Your impact begins here As Regulatory Submission Professional, you will help clinical trials across the Novo portfolio reach health authorities on time and in the right shape.
You will plan and coordinate Clinical Trial Application distributions worldwide and contribute to EU submissions through CTIS, in a newly established setup that adds flexibility during peak periods. Your work keeps trial timelines moving, helps shape how we work and supports the progress that brings new treatments closer to people living with serious chronic diseases.
What you’ll bring You know your way around regulatory or clinical work and enjoy keeping many moving parts on track.
We are looking for
- A master’s degree (MSc) in life science or a relevant field. - At least 2 years of experience in Regulatory Affairs, Clinical Operations or a closely related area.
- Regulatory knowledge in one or more areas, such as regulatory requirements in the EU, US, China or Japan, early- or late-stage drug development, life cycle management, label or device development, health authority interactions or regulatory intelligence1 …
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