Regulatory Affairs Professional

Category:  Reg Affairs & Safety Pharmacovigilance
Location: 

Søborg, Capital Region of Denmark, DK

   

Do you have experience in regulatory affairs within the pharmaceutical or biotechnology sectors, developing and managing regulatory submissions and documentation? Can you ensure compliance across the regulatory lifecycle and translate complex requirements into clear, actionable plans? Are you skilled in drug development and able to partner with crossfunctional teams to support timely regulatory approvals?

 

Then you could be the one we are looking for. Join us as a Regulatory Affairs Professional and help ensure safe, compliant, and successful development and approval of medicines.

 

Your new role

As our new Regulatory Affairs Professional you will be responsible for a wide range of tasks such as:

  • Develop and manage regulatory submissions and documentation across US, EU, and RoW.
  • Plan and coordinate submission and roll-out of Sema NDAs and brand variations.
  • Create content plans for various submission types, including NDAs/MAAs, variations, and supplements.
  • Prepare country-specific Module 1 documents and regional submission components.
  • Ensure compliance with regulatory agency requirements and regional laws.

 

Your new department       

The RA SEMA Diabetes team is a department under the RA OCH VP area responsible for defining and driving regulatory strategies the semaglutide Diabetes products. We work as an integrated part of the global development and research projects and play a key role in the cross-functional teams. The RA SEMA Diabetes department consists of 12 team members with various experiences all working towards a shared mission of optimizing the commercial opportunities for semaglutide Diabetes products by developing bold regulatory strategies, shape best-in-class labels and accelerating regulatory submissions & approvals

 

 

Your skills & qualifications

We're seeking candidates who fulfil the following prerequisites:

  • You hold a Bachelor or Master of Science (life sciences) and/or a relevant PhD
  • You have 3-7 years of experience in regulatory affairs within the pharmaceutical or biotechnology sectors.
  • You have proven expertise in product registration, regulatory strategy, and adherence to agency requirements.
  • You are fluent in written and spoken English

 

As a person you bring deep regulatory expertise and enterprise thinking, combining strategic vision with strong attention to detail. You communicate effectively, negotiate confidently, and solve problems creatively while managing projects to deliver results. You excel in crossfunctional collaboration, adapt quickly to changing priorities, and apply analytical thinking to drive informed decisions.

 

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity. For over 100 years, this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.

 

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

 

More information

If you have additional questions about the position before applying, please contact Trine Cecilia Thy Gregersen, Associate Director, on tctg@novonordisk.com

 

Deadline

8th of March 2026

 

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

 

We will be reviewing application on an ongoing basis, so please submit your application at your earliest convenience.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

 

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.