Novo Nordisk as an Associate Regulatory Professional II - Clinical Trial Submissions Manager
Novo Nordisk, a leading global healthcare company, is seeking an experienced Associate Regulatory Professional II for Clinical Trial Submissions Management in Bangalore. This role offers an opportunity to contribute to impactful clinical trials and make a difference in patient lives.
Key Responsibilities:
- 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).
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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.
Novo Nordisk Hiring Associate Regulatory Professional II - Clinical Trial Submissions Manager in Bangalore[/caption]
About the Department: You will join the EU Submission Hub, a dynamic team focused on clinical trial submissions in the EU. This department plays a crucial role in electronic submissions to Health Authorities, contributing to regulatory excellence.
Working at Novo Nordisk: Novo Nordisk is committed to defeating chronic diseases and improving patient lives globally. Join a diverse and collaborative team driving impactful healthcare solutions. Apply now to be part of this transformative journey.
