Regulatory Professional I – EU Submission Hub
Location: Bangalore, India
Category: Regulatory Affairs & Safety / Pharmacovigilance
Job Type: Full-Time
Application Deadline: 19th January 2026
About the Role
Novo Nordisk is seeking a Regulatory Professional I to join our EU Submission Hub team. This role is pivotal in managing clinical trial applications (CTAs) in the EU, ensuring compliance with EU Clinical Trial Regulation (CTR), and supporting the regulatory life cycle of clinical trials. You will collaborate with cross-functional teams across Europe and India, contributing to process improvements, regulatory compliance, and innovation.
Key Responsibilities
Manage initial clinical trial application submissions in the EU and oversee changes throughout the trial lifecycle.
Maintain and quality-check clinical trial documents in CTIS (Clinical Trial Information System).
Coordinate responses to requests from Health Authorities and Ethics Committees.
Ensure timely submissions and support project teams in regulatory decision-making.
Shape and enhance processes for future clinical trial submissions in the EU.
Collaborate with IT platforms, including Veeva Vault RIM and Vault Clinical (COSMOS).
Support continuous improvement initiatives and ensure adherence to regulatory guidelines.
Qualifications & Experience
Required:
Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, or Health Sciences.
Minimum 5 years of experience in regulatory affairs or clinical trial submissions.
Strong knowledge of EU CTR and CTIS, including document uploading and Part I/Part II processes.
Fluent in written and spoken English.
Preferred:
Experience with Veeva Vault RIM and Vault Clinical platforms.
Knowledge of global regulatory requirements for clinical trials.
About the Team
The EU Submission Hub is a hybrid, international team with colleagues based in Denmark, Poland, and Bangalore. The team focuses on clinical trial submissions in the EU, delivering regulatory excellence in a collaborative, innovative, and supportive environment.
Why Join Novo Nordisk
Work with a global leader in diabetes and chronic disease management.
Make a direct impact on clinical trials affecting millions of patients.
Join a diverse, collaborative, and inclusive team.
Contribute to innovative regulatory processes that drive healthcare advancement.
Novo Nordisk is an equal opportunity employer, committed to inclusive hiring and fraud-free recruitment processes. Applicants are encouraged to apply directly through official Novo Nordisk channels.
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