Regulatory Professional - Clinical Trial submissions in EU (Denmark, Søborg)

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Reg Affairs & Safety Pharmacovigilance

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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. This position offers the unique opportunity to work in an international environment with European exposure, collaborating closely with different affiliates.
If you are passionate about driving change and navigating complex agendas, apply today for a life-changing career.

The position
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 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).

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

• A Bachelor´s degree, master’s degree in life science or relevant field.
• Minimum few years of experience in working with clinical trials and submissions.
• Experience in working with Vault RIM and Vault Clinical (Veeva platforms).
• EU Clinical Trial Regulation 536/2024 (EU CTR) understanding and experience.
• Experience working with Clinical Trial Information System (CTIS) is big advantage.
• Fluency in written and spoken English.

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.

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. 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.

Contact
For further information, please contact Team Leader Asta Ruleviciute, at [email protected].

Deadline
29 December 2024.
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.