Job Title: Associate Regulatory Professional II – Clinical Trial Submissions
Company: Novo Nordisk
Category: Regulatory Affairs & Safety Pharmacovigilance
Location: Bangalore, Karnataka, India
Department: EU Submissions Hub
About Novo Nordisk: Novo Nordisk is a leading global healthcare company with a mission to ensure that people living with chronic diseases can live full lives. With a focus on defeating serious chronic diseases, particularly within diabetes, Novo Nordisk impacts millions of patient lives daily. As a company committed to driving change, Novo Nordisk values diversity, inclusivity, and collaboration among its 63,000+ employees worldwide.
Job Description: As an Associate Regulatory Professional II, you will be an integral part of the Global Regulatory Affairs team at Novo Nordisk. Your primary responsibility will be managing initial clinical trial application submissions in the EU, adhering to the Clinical Trial Regulation (EU CTR), and overseeing changes throughout the clinical trial life cycle. You will collaborate with various submission teams across the organization and ensure accurate data management in the Clinical Trial Information System (CTIS). Additionally, you will coordinate responses to requests for information from Health Authorities and Ethics Committees, contribute to project team decisions, and shape the future setup of new processes for submitting Clinical Trial Applications (CTAs) in the EU.
Responsibilities:
- Manage initial clinical trial application submissions in the EU and oversee changes during the clinical trial life cycle.
- Maintain accurate data in the Clinical Trial Information System (CTIS) and ensure timely submissions.
- Coordinate responses to requests for information from Health Authorities and Ethics Committees.
- Contribute to project team decisions and shape future processes for submitting Clinical Trial Applications (CTAs) in the EU.
- Collaborate with different IT platforms, such as Veeva Vault RIM and Vault Clinical (COSMOS).
Qualifications:
- 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.
- Knowledge of Vault RIM and Vault Clinical (Veeva platforms) is advantageous.
- Strong team player with excellent organizational and problem-solving skills.
- Ability to thrive in a fast-paced environment and work well under pressure.
- Effective communicator with the ability to collaborate at all organizational levels.
- Curious mindset with a passion for learning and working with data and systems.
- Comfortable working in a virtual multi-cultural team environment.
About the Department: You will be a member of the newly established EU Submission Hub, a virtual team with colleagues in Denmark, Portugal, Poland, and Bangalore. The EU Submission Hub focuses on clinical trial submissions in the EU and is part of the Submission Management department, responsible for electronic submissions to Health Authorities.