Regulatory Affairs Specialist in RA Rare Bleeding and Hematorenal Disorders

Do you want to be part of an exciting environment where engaged people are committed to optimize Novo Nordisk’s medicines across the globe? Would you like to join a team with a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders? If yes, join us as a Regulatory Affairs Specialist. Regulatory Affairs (RA) is a truly interesting and challenging place to work, so apply today!

Your new role

As Regulatory Affairs Specialist, you will be responsible for developing regulatory strategies and lead their execution via interaction with cross-functional teams. You will lead, drive and coordinate several regulatory activities related to the Novo Nordisk RA Rare Bleeding Disorders portfolio. This will entail close collaboration with the Global Regulatory Lead. 

Your main responsibilities will include:

• Contributing with regulatory expertise to global strategies and tactics, by analysing regulatory opportunities and risks
• Leading major submission tracks such as briefing packages for meetings with Health Authorities, clinical trial applications, and global submission strategies, working with affiliates to ensure alignment between local and global regulatory strategies and timely preparation of documentation

You will report to the head of the department and take active part in department related activities, including improvement projects across RA.

Your new department

RA Rare Bleeding Disorders department is part of Global Regulatory Affairs and situated in Søborg, Denmark. We are contributing to the development of different products and projects within Rare Bleeding Disorders with a pipeline including a variety of different modalities and technologies including gene therapy.

We are a department with 14 dedicated and highly engaged employees of 8 different nationalities with diverse backgrounds and experiences. We work in a flexible set-up where trust & openness, sparring, challenge and knowledge sharing fosters an inclusive and innovative culture we all enjoy being part of. While flexible work is valued, the job requires physical presence to enable effective discussion, knowledge sharing, and strong team connections. We work as an integrated part of the global development, research project teams and cross-functional sub-teams. We are responsible for the regulatory strategies and provide regulatory expertise and tactics to the product development plan. We drive product labelling, Health Authority interactions and clinical trial applications.

Your skills & qualifications

We are looking for a person with a strong regulatory and scientific foundation who can contribute effectively to global regulatory activities. You should be able to work independently within a cross-functional environment and demonstrate sound decision-making based on regulatory principles.

To succeed in this role, you bring:

• A master’s degree or Ph.D. in science, pharmaceutical or health science
• Minimum 7-8 years of experience in Regulatory Affairs or other relevant area in drug development
• Practical knowledge in defining and developing global regulatory strategies and good all-around understanding of the regulatory documentation and requirements for pharmaceutical development and licensing
• Excellent project management skills and ability to cooperate at any organizational level
• Change-oriented approach and a willingness to experiment
• Ability to quickly learn and navigate new digital solutions and regulatory databases to support submission processes and cross-functional collaboration
• Strong communication skills in verbal and written English

On a personal level, you bring a proactive and positive approach, communicate effectively across the organization and work well in dynamic situations. You are comfortable sharing your perspective, approaching challenges with curiosity and flexibility, and taking ownership of your work and continuous development. You stay focused under pressure, adapt to change with ease and contribute constructively to collaborative problem-solving. You are proficient in common IT tools and systems relevant to regulatory affairs, including Microsoft Office and electronic document management platforms