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Reg Affairs & Safety Pharmacovigilance

Are you passionate about drug development and regulatory compliance? Do you want to play a pivotal role in shaping the future of healthcare by ensuring fast and efficient regulatory approvals? If so, we invite you to join our team as a Regulatory Affairs Professional in Søborg, Denmark. Take the lead in a fast-paced, high-impact project and help Novo Nordisk make a difference for patients worldwide.

Read on and apply today for a life-changing career.

The position
As a Regulatory Affairs Professional, you will have the opportunity to work on a project being developed towards phase 2 and 3, with a lot of focus and fast pace.

You will be in the center of project planning and execution in close collaboration with your RA CMC project team, responsible for planning and coordinating the regulatory documentation and set the strategic regulatory direction for the project. The role is to work in a fast-paced project, so most importantly you are expected to demonstrate drive, good energy and eagerness to learn. Other responsibilities may include:

• Execute the strategies developed by experienced colleagues in accordance with CMC development activities and ensure submissions to key markets
• Help turn scientific progress into regulatory pathways.
• Apply CMC regulatory intelligence to develop robust regulatory strategies
• Identifying as well as improving regulatory CMC practices, processes and approaches re-lated to regulatory CMC documentation and strategies
• Act as a point of contact for assigned activities, drive discussions, and ensure that rele-vant information is conveyed to the rest of your RA CMC team

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

Our commitment to innovation also applies to the way we work. We therefore embrace the hy-brid workplace, blending home office and on-site work in Søborg, Denmark, where the global RA CMC & Device department is based.

Qualifications
To succeed in the role, we expect you to have:
• A Master degree in science, pharmacy, biology, or similar
• It is a benefit if you have 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)
• Show an interest for processes and systems, which underlines everything we do in Regulatory Affairs CMC
• The ability to communicate topics related to protein chemistry, analytical chemistry, manufacturing of drug substances, and drug products scientifically and professionally with your colleagues
• Excellent communication skills, both written and spoken, with fluency in English.

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

About the 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.

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.

Contact
For more information regarding the role, please contact Anne Hjort Bendsøe at +45-30753793.

Please note that the Hiring Manager will be out of office from 12 July to 3 August 2025.

Deadline
01 August 2025.

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

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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