Job Description

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Associate Regulatory Professional II - Clinical Trial Submissions
Category: Reg Affairs & Safety Pharmacovigilance
Location:
Bangalore, Karnataka, IN
Department: EU Submissions Hub
Are you ready to make a difference in the lives of millions of people living with a serious chronic disease? Join Novo Nordisk, a proud life-science company on a mission to ensure that people living with a chronic disease can live a full life. We are looking for a dedicated EU Submission Lead for Clinical Trials to join our Global Regulatory Affairs team.
If you are passionate about driving change and navigating complex agendas, apply today for a life-changing career.
The position
As Associate Regulatory Professional II, you will play a crucial role in driving, coordinating, and actively following up on multiple tasks with challenging timelines. Your responsibilities will include:

• 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).

Qualifications
We expect you to have:

• Bachelor\xc2\xb4s 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.

About the department
You will be a member of a newly established virtual team - EU Submission Hub with colleagues in Denmark, Portugal, Poland and Bangalore focusing on clinical trial submissions in EU. EU Submission Hub is part of Submission Management department, who is responsible for electronic submissions to Health Authorities including New Drug Applications and Life Cycle submissions.
Working at Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we\'re working toward something bigger than ourselves, and it\'s a collective effort. Join us! Together, we go further. Together, we\'re life changing.
Contact
If you believe you are a match for the above requirements and are willing to take up the role, please apply here with our online application tool.
Deadline
Apply on or before: 21st August 2024
Disclaimer
It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we\'re life changing.