Associate Regulatory Professional II

3 weeks ago

bangalore, India Novo Nordisk AS Full time

Department: EU Submissions Hub

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 Associate Regulatory Professional II, 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 (uploading and QC) 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).

Qualifications

We expect you to have:

Bachelor´s degree, master’s degree, or Ph.D. in science, pharmaceutical or health science.

At least 3+ years of experience in regulatory affairs or clinical trials.

Fluent written and spoken English.

Vault RIM and Vault Clinical (Veeva platforms) knowledge would be an advantage.

On personal level :

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.

You love data and working in systems.

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.

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