(Senior) Regulatory Affairs CMC Professional - 8 months maternity cover

Category:  Reg Affairs & Safety Pharmacovigilance
Location: 

Søborg, Capital Region of Denmark, DK

   

We are looking for a (Senior) Regulatory Affairs Professional to join RA CMC & Device, Diabetes & Obesity’s, part of Novo Nordisk's Development organization. This may be the opportunity for you, if you are passionate about drug development and want to be a subject matter expert in a leading international organization as you will have the opportunity to take the lead and set the strategic direction working with products of great importance to Novo Nordisk’s growth on a global level.

 

Your new role

As a (Senior) Regulatory Affairs Professional, you will have the opportunity to work with late-stage development and life-cycle management submissions worldwide.

You will be in the center of project planning and execution – responsible for planning, coordinating, and reviewing regulatory documentation related to the drug e.g., supporting preparation of applicable sections of submission packages, responses to agency questions for global markets and Agency Meeting Packages.

More specifically, you will be accountable for:

  • Planning, executing and driving strategic regulatory CMC activities
  • Apply CMC regulatory intelligence to develop robust regulatory strategies
  • Identifying as well as improving regulatory CMC practices, processes and approaches related to regulatory CMC documentation and strategies.

 

Your new department

Novo Nordisk Regulatory Affairs CMC & Device makes medicine available to patients around the world by ensuring fast regulatory submissions and approvals in all our global markets. The RA CMC Diabetes & Obesity area consists of approximately 100 highly skilled, dedicated colleagues with diverse backgrounds and experiences who are involved in every Regulatory CMC aspect concerning products and projects in these areas. As Novo Nordisk’s product portfolio grows, we are developing and implementing highly diverse CMC solutions to complex manufacturing processes; therefore, we are looking to expand our team of experts within RA CMC.

 

Your skills and qualifications

To succeed in the role, we expect you to have:

  • An Academic degree in science, pharmacy, biology, or similar
  • At least, 1-2 years of relevant experience in the pharmaceutical industry, particularly within a CMC-related area.
  • A good scientific and technical mindset, along with a thorough understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytics, and quality assurance)
  • Excellent communication skills, both written and spoken, with fluency in English.
  • Great communication skills as all work takes place in multidisciplinary project groups.

 

In this role, your collaborative skills will be well-trained and further developed, allowing you to build an extensive internal network.

On a personal level, you are a curious, well-organized, and proactive problem solver who thrives in dynamic environments. With a can-do attitude and strong teamwork skills, you adapt to change effectively while bringing innovation and independence to overcoming.

 

Working at Novo Nordisk

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.

 

More information

For more information regarding the role, please contact Mette Enghuus Jørgensen at +45 3448 2599.

 

Deadline for application         

4th of January 2026.

 

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

 

We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.