Website Novo Nordisk
Job Title: Associate Regulatory Professional II – Clinical Trial Submissions
About Novo Nordisk
Join Novo Nordisk, a global leader in healthcare with nearly nine decades of pioneering work in diabetes care. We also hold leading positions in Haemophilia care, growth hormone therapy, and hormone replacement therapy. We are currently seeking an experienced professional to join our newly established virtual team, the EU Submission Hub. This team, with members in Denmark, Portugal, Poland, and Bangalore, focuses on clinical trial submissions within the European Union.
About the Department
The EU Submission Hub is part of the Submission Management department, responsible for electronic submissions to Health Authorities, including New Drug Applications and Life Cycle submissions. As a member of this team, you will play a critical role in ensuring the success of our clinical trial submissions in the EU.
Key Responsibilities
As an Associate Regulatory Professional II, your key duties will include:
- Collaboration: Work closely with submission teams across various regions and countries in Europe.
- Clinical Trial Submissions: Manage initial clinical trial application submissions in the EU, adhering to the Clinical Trial Regulation (EU CTR) and handling all changes throughout the trial lifecycle.
- Document Management: Maintain and ensure the accuracy of documents in the Clinical Trial Information System (CTIS).
- Coordination: Coordinate responses to requests from Health Authorities and Ethics Committees, ensuring timely and accurate submissions.
- Process Improvement: Contribute to the development of new processes for Clinical Trial Applications (CTAs) in the EU.
- System Collaboration: Work with IT platforms like Veeva Vault RIM and Vault Clinical (COSMOS) to streamline submission processes.
Candidate Profile
We are looking for a candidate who possesses the following qualifications and skills:
- Educational Background: Bachelor’s, Master’s, or Ph.D. in science, pharmaceutical, or health sciences.
- Experience: Minimum of 3 years in regulatory affairs or clinical trials.
- Technical Skills: Knowledge of Vault RIM and Vault Clinical (Veeva platforms) is an advantage.
- Language Proficiency: Fluent in written and spoken English.
- Soft Skills: Strong team player, well-organized, detail-oriented, with excellent problem-solving skills. Able to maintain a positive attitude under pressure.
- Communication: Skilled communicator capable of working at all organizational levels.
- Learning Mindset: Curious, loves learning new things, and enjoys working with data and systems.
- Team Collaboration: Comfortable working in a virtual, multicultural team environment.
Additional Information
- Experience: 3+ years
- Qualification: Bachelor’s, Master’s, or Ph.D. in science, pharmaceutical, or health science
- Location: Bangalore, Karnataka
- Industry Type: Pharma/Healthcare/Clinical Research
- Functional Area: Clinical Trial Submissions
- End Date: 30th August 2024
If you are passionate about making a difference and thrive in a challenging yet rewarding environment, we encourage you to apply for this exciting opportunity at Novo Nordisk.
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