Regulatory Professional I – EU Clinical Trial Submissions
Job Category: Regulatory Affairs & Safety / Pharmacovigilance
Department: EU Submission Hub
Location: Bengaluru, Karnataka, India
Work Model: Hybrid
Employment Type: Full-Time
Experience Required: Minimum 5 Years
Application Deadline: 19 January 2026
Job Overview
Novo Nordisk Global Business Services (GBS), India, is seeking an experienced Regulatory Professional I to join its EU Submission Hub in Bengaluru. This role offers an excellent opportunity to contribute to global clinical trial submissions while ensuring regulatory compliance under the EU Clinical Trial Regulation (EU CTR).
As part of a newly established, cross-country regulatory team, the incumbent will play a key role in managing EU clinical trial application submissions, lifecycle updates, and interactions with regulatory authorities—supporting Novo Nordisk’s mission to improve the lives of patients with serious chronic diseases worldwide.
Key Responsibilities
Collaborate closely with global regulatory submission teams across multiple European countries
Manage initial clinical trial application (CTA) submissions in the EU in compliance with EU CTR requirements
Oversee lifecycle management of clinical trial submissions, including amendments and updates
Upload, maintain, and quality-check regulatory documentation in the Clinical Trial Information System (CTIS)
Ensure accuracy and completeness of clinical trial data within CTIS (Part I and Part II submissions)
Coordinate and support responses to requests for information from Health Authorities and Ethics Committees
Ensure timely regulatory submissions and contribute to project-level decision-making
Support the development and optimization of new regulatory submission processes for EU clinical trials
Work with regulatory IT platforms such as Veeva Vault RIM and Vault Clinical (COSMOS)
Maintain compliance with internal SOPs, regulatory standards, and submission timelines
Education & Experience Requirements
Bachelor’s or Master’s degree in Pharmaceutical Sciences, Life Sciences, or Health Sciences
Minimum 5 years of hands-on experience in regulatory affairs or clinical trial submissions
Proven experience working with EU Clinical Trial Regulation (EU CTR) and CTIS
Required Skills & Competencies
Strong knowledge of EU CTR and end-to-end CTIS submission processes
Proficiency in document management, regulatory publishing, and submission lifecycle activities
Fluency in written and spoken English
Ability to collaborate effectively with cross-functional and multicultural teams
Strong organizational skills with the ability to manage multiple submissions simultaneously
High attention to detail and commitment to regulatory compliance
Experience with Veeva Vault RIM and Vault Clinical is an added advantage
About the Department
The EU Submission Hub is a newly formed hybrid team within Novo Nordisk’s Submission Management function. The team supports EU clinical trial submissions and works across Denmark, Poland, and India. Based at Novo Nordisk GBS Bengaluru, the department fosters a collaborative, high-performance culture focused on regulatory excellence, innovation, and continuous improvement.
Working at Novo Nordisk
Novo Nordisk is a global healthcare leader committed to defeating serious chronic diseases and advancing long-term patient health. For over a century, the organization has combined scientific innovation with a strong people-first culture. Employees are empowered to challenge conventions, collaborate globally, and contribute to meaningful healthcare outcomes.
Equal Opportunity & Fraud Disclaimer
Novo Nordisk is committed to an inclusive recruitment process and equal opportunity for all applicants. The company does not charge any fees or request funds during recruitment and does not issue unsolicited job offers.
Please note that job titles may be subject to global alignment and may change during the recruitment process.
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Regulatory Affairs Jobs in Bangalore, EU Clinical Trial Submissions, Regulatory Professional Jobs India, CTIS Regulatory Careers, EU CTR Regulatory Specialist, Pharma Regulatory Affairs India, Novo Nordisk Careers Bengaluru
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