EU Submission Lead for Clinical Trials - Regulatory Professional

Category:

Reg Affairs & Safety Pharmacovigilance

Are you ready to make a difference in the lives of millions of people living with a serious chronic disease? Join Novo Nordisk, a proud life-science company on a mission to ensure that people living with a chronic disease can live a full life. We are looking for a dedicated EU Submission Lead for Clinical Trials to join our Global Regulatory Affairs team.

If you are passionate about driving change and navigating complex agendas, apply today for a life-changing career.

The position
As an EU Submission Lead for Clinical Trials, 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) in the EU
• Collaborating with different IT platforms, such as Veeva Vault RIM and Vault Clinical (COSMOS).

This is a remote-work position, and relevant candidates based in EU countries are welcome to apply.

Qualifications
We expect you to have:

• Bachelor´s degree, master’s degree, or Ph.D. in science, pharmaceutical or health science
• At least 2 years of experience in regulatory affairs or clinical trials
• Vault RIM and Vault Clinical (Veeva platforms) knowledge would be an advantage
• Fluent written and spoken English.

On personal level you are:

• Strong team player
• Well organised, structured, and detailed oriented
• Have solid problem-solving capabilities
• Can keep your spirits high even when under pressure
• Skilled communicator who can cooperate at any organisational level
• Curios and like learning new things
• Enjoy working with people online and want to be part of virtual multi-cultural team.

About the department

You will be a member of a newly established virtual team - EU Submission Hub with colleagues in Denmark, Portugal, Poland and Bangalore focusing on clinical trial submissions in EU. EU Submission Hub is part of Submission Management department, who is responsible for electronic submissions to Health Authorities including New Drug Applications and Life Cycle submissions.

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 further information, please contact Team Leader Asta Ruleviciute, +4530776259

Deadline
1st April 2024

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 process, please refrain from adding a photo in your CV.

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.