Regulatory Professional I

2 months ago

Bengaluru, India Novo Nordisk Full time

**Department: Global Regulatory Affairs
- GBS - EU Submission Hub**

**About the Department**

Global Regulatory Affairs (GRA) in Global Business Services (GBS) Bangalore is a global RA hub consisting of high calibre regulatory professionals. The objective of the team is to offer core RA competencies enabling NN secure fast, high quality product approvals. The team delivers full strategic and operational support on a global scale across value chain on core regulatory processes across NN product portfolio. We provide regulatory expertise and work very closely with our colleagues in RAHQ, Denmark (DK) as well as colleagues in our affiliates all over the world. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs truly interesting and challenging to work. The department is committed towards innovation on the way we work: We embrace a flexible workplace, with a blend of in-office and remote work. You will become part of virtual international team consisting of 8 employees: 4 in EU and 4 in India. EU Submission Hub team is part of CTA mgmt. department and anchored in HQ under RA Diabetes & Obesity area. EU Submission Hub team is based on strong teamwork mindset and collaboration with stakeholders.

**The Position**:

- Uploading & maintaining documents in Clinical Trial Information System (CTIS), performing relevant Quality checks on the documents & data about clinical trials, monitor CTIS for relevant information to share in the organisation & manage user access received for CTIS. We expect you to be proactive, have attention to detail, challenge the discussions and contribute to project team decisions.
- Drive Clinical Trial Application submission planning with stakeholders and handle RFI (Request for Information) meetings with HQ and affiliates.
- It is crucial that you are flexible and easily adapt to a changing job environment. As new processes for submitting CTAs (Clinical Trial Application) in EU are still under development, you will be involved in shaping the future set up while at same time providing stability for new clinical trial submissions under EU Clinical Trial regulation via CTIS.
- Furthermore, you are passionate & enjoy working with different IT platforms, like Veeva Vault RIM and Vault Clinical (COSMOS).

**Experience**:

- 5+ years of relevant work experience within Regulatory Affair’s along with Master’s degree in Bioscience, Lifesciences, Biotechnology.
- Intermediate knowledge on Regulatory and Clinical IT systems & tools.
- Excellent communication and presentation skills.
- Good understanding on R&D Value Chain and pharmaceutical industry.
- Ability to cross collaborate and work with the teams from different background in a Hybrid setup.

**Working At Novo Nordisk**

We are a proud life-science company, and life is our reason to exist. We’re in-spired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific re-search, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

**Contact**

**Deadline**

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.

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