Regulatory Professional I

Department : EU Submission Hub

Location : : Bangalore Novo Nordisk Global Business Services (GBS) India

Are you passionate about regulatory affairs and clinical trials Do you want to play a key role in ensuring compliance and driving change in a global organisation Join Novo Nordisk as a Regulatory Professional I in our EU Submission Hub team and make a difference in the lives of millions of people living with serious chronic diseases. If this sounds like the opportunity youve been looking for read on and apply today!

The position

As a Regulatory Professional I you will have the opportunity to make a significant impact by:

• • Working closely with various submission teams across the organisation 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 quality checking) 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 are looking for a dedicated professional with the following qualifications:

• • A bachelors degree or masters degree in pharmaceutical or health science.
  • Minimum of 5 years experience in regulatory affairs or clinical trials.
  • Fluent written and spoken English.
  • Knowledge of EU CTR and CTIS (including how to upload documents and understanding the full CTIS structure for Part I and Part II).
  • Nice to have knowledge of Vault RIM and Vault Clinical (Veeva platforms).

About the department

You will be a member of our newly established hybrid team the EU Submission Hub which focuses on clinical trial submissions in the EU. Our team is part of the Submission Management department and includes colleagues based in Denmark Poland and Bangalore. The team thrives in a collaborative and supportive environment working together to ensure regulatory compliance and drive innovation in clinical trial submissions. Located at Novo Nordisk GBS in Bangalore you will be part of a dynamic and diverse workplace that values teamwork innovation and making a difference.

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.

Contact

To submit your application please upload your CV online (click on Apply and follow the instructions).

Deadline

19th January 2026

Disclaimer

It has been brought to our attention that there have recently been instances of fraudulent job offers purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organisations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process.

Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Were not your typical healthcare a modern world of quick fixes we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science make healthcare more accessible and treat prevent and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real lasting change in health.