Regulatory Professional - Gladsaxe, Capital Region of

Research & Development · Soeborg, Denmark · Are you looking for something new and exciting, a job where you could make a difference? Do you want to join a team where action never stops, and every day never looks the same? Do you love working in international environment surrounde ...

Jobbeskrivelse

Research & Development
Soeborg, Denmark
Are you looking for something new and exciting, a job where you could make a difference? Do you want to join a team where action never stops, and every day never looks the same? Do you love working in international environment surrounded by people with different backgrounds and cultures? We are seeking a highly qualified individual to join our team – Regulatory Professional.

Apply today and join a newly established virtual team – with colleagues in Denmark, Poland and India - focusing on clinical trial submissions in EU.

Your new role
Responsibilities
As Regulatory Professional, you will play a crucial role in driving, coordinating, and actively following up on multiple tasks with challenging timelines. Your responsibilities will include:

• Working on process optimisation for CTA submissions within a team and stakeholders from other teams.
• Working closely with various submission teams across the organization and all countries in Europe
• Managing initial clinical trial application submissions in the EU according to the Clinical Trial Regulation (EU CTR) and all changes during the life cycle of clinical trials
• Maintaining documents in the Clinical Trial Information System (CTIS) and ensuring accurate data about clinical trials
• Coordinating responses for requests for information from Health Authorities and Ethics Committees
• Ensuring timely submissions in CTIS and contributing to project team decisions.
• Shaping the future setup of new processes for submitting Clinical Trial Applications (CTAs)
• Collaborating with different IT platforms, such as Veeva Vault RIM and Vault Clinical (COSMOS).

The complexity of the tasks will be tailored to the candidate's level of experience.

Your new department
You will be a member of a hybrid team - EU Submission Hub with colleagues in Denmark, Poland and India focusing on clinical trial submissions in EU. The team consists in total of 11 employees who work very close with many different teams in HQ function and all EU/EEA countries. EU Submission Hub is anchored in RQ&C Operations VP area.

Employees in DK located in Søborg office and in Poland in Warsaw office.

Your Skills And Qualifications
To succeed in this role, we expect you to have:

• Master's degree in life science or relevant field.
• • 5 years of experience in working with clinical trials and submissions.
• EU Clinical Trial Regulation 536/2024 (EU CTR) understanding and experience.
• Experience in working with Vault RIM and Vault Clinical (Veeva platforms), it's a plus.
• Experience working with Clinical Trial Information System (CTIS) (how to upload documents and knowledge of full CTIS structure for Part I and part II) – is a big advantage.
• Fluency in written and spoken English.
• Experience with improvement of work flows/optimisation projects.

As a person, you thrive as a team player in collaborative environments, showcasing strong organisational skills, attention to detail, and adept problem-solving abilities. Your resilient approach allows you to thrive under pressure and maintain a positive outlook. Your effective communication skills enable seamless cooperation across all levels of an organisation. Your inquisitive nature drives a passion for continuous learning, particularly in working with data and systems. You are enthusiastic about the prospect of collaborating with a diverse online community as part of a virtual team. Furthermore, for this role, we expect the candidate to demonstrate leadership skills and the ability to independently drive and deliver results.

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.

Deadline
4 March 2026.

Please note that applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.

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.

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.