Regulatory Professional I

2 weeks ago

Bengaluru, India Novo Nordisk Full time

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 (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 few 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. Working at Novo Nordisk Novo Nordisk is a leading global healthcare company with a -year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63, employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us Together, we go further. Together, we’re life changing.

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