Job Description

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Associate Regulatory Professional II - EU CTR

Category: Regulatory

Location:

Bangalore, Karnataka, IN

Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, "Raise your handaEUR as there is an exciting opportunity waiting for you as "Associate Regulatory Professional II - (EU clinical trials)aEUR with us. "Apply nowaEUR - At Novo Nordisk we assure you will experience the best.

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 Position

As an Asst. Regulatory professional, you will be required to coordinate and actively follow-up on several tasks with challenging and often overlapping timelines. In this role, you will work closely with various submission teams across the organisation and all countries in Europe. You will be part of initial clinical trial application submissions in EU and all changes during life cycle of clinical trials. As part of this role, you will be responsible for 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.

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

• 3+ years of relevant work experience within Regulatory Affair's along with Master's degree in Bioscience, Lifesciences, Biotechnology.
• Intermediate understanding on Clinical trials process, clinical trials application (CTA) & EU clinical trials requirements.
• 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

At Novo Nordisk, we don't wait for change. We drive it. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of expermentation, striving for excellence without fixatingon perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales- we're all working to move the needle on patient care.

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:19th October, 2022

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.