(Senior) Regulatory Professional  - Clinical Trial Submissions in EU

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? 
Then come and join a newly established virtual team – with colleagues in Denmark, Poland and Bangalore - focusing on clinical trial submissions in EU.

The position
We are seeking two highly qualified individuals to join our team – a Regulatory Professional and a Senior Regulatory Professional. The position level will be determined based on the candidate's seniority, experience, skills, and competencies. 

As (Senior) 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 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).

For the senior level position, youwill be less involved in system- related tasks and focusmore on process improvements and support teammates with various tasks and questions.  

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 one of the offices in Denmark, Poland or India.

Qualifications
To succeed in this role, we expect you to have:
•    A Bachelor´s degree and/or master’s degree in life science or relevant field.
•    Minimum 3 or more 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) is big advantage.
•    Fluency in written and spoken English.
•    For senior level position experience with working process improvement/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 systemsYou are enthusiastic about the prospect of collaborating with a diverse online community as part of a virtual team. . Furthermore,  for the senior level role, we expect the candidate  to demonstrate leadership skills and the ability to independently drive and deliver results.  

About the department
You will be a member of a newly established virtual team - EU Submission Hub with colleagues in Denmark, Poland and Bangalore focusing on clinical trial submissions in EU. Team consists in total of 13 employees who work very close with many different teams in HQ function and all EU/EEA countries. EU Submission Hub is anchored in RA Submissions VP area and employees in DK located in Søborg office. 

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.
 
Deadline
16 March 2025. 
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 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.