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RA Product Specialist

2 weeks ago

Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time
We are seeking a highly skilled Regulatory Affairs Professional to join our RA CMC & Device organization, handling RA CMC activities for our marketed Oral Products at Novo Nordisk A/S. As a key member of our team, you will play a vital role in ensuring fast and successful regulatory submissions and approvals in all global markets.

The ideal candidate will have a Master's degree or PhD in a relevant field, such as pharmaceutical science, chemistry, or biology, and at least 3-4 years of experience within the pharmaceutical industry, preferably in areas like manufacturing, product supply, process development, analytics, or quality assurance. Strong communication skills, a proactive and positive approach to challenges, and the ability to thrive in a diverse team environment are essential qualifications for this role.

In this position, you will plan, coordinate, and execute regulatory submissions, define and drive updates to quality documentation packages, identify and improve RA CMC practices, processes, and approaches related to RA CMC documentation and strategies. You will also collaborate with cross-functional teams to ensure seamless execution of regulatory initiatives.

We offer a dynamic and collaborative work environment, with opportunities for individualized onboarding, flexibility, empowerment, and development. Well-being and psychological safety are major focuses, and we strive for a modern way of working, including friendly colleagues, camaraderie, and space to be proactive, learn, and take the initiative to improve and make a difference.

As a part of our team, you will be empowered to drive change and contribute to the success of our expanding product portfolio.