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Regulatory Data Specialist

Category:  Regulatory
Location: 

Søborg, Capital Region of Denmark, DK

   

We are transforming the way Regulatory Affairs is operating! Would you like to be a part of an exciting journey? Take a look at this job opportunity!

 

About the department

In this role, you will have the unique opportunity to be part of a strategically crucial business transformation program across multiple processes and geographies and take active part in shaping the way Regulatory Affairs (RA) will work in the future. You will join the RA Business Transformation department that plays a key role to support and enable this transformation.

Global Regulatory Affairs is an exciting area involved across the full value chain. We are responsible for global regulatory strategies to obtain and maintain regulatory licenses for current and future products, responsive to the worldwide business needs of Novo Nordisk.

 

The position

The Regulatory Data Specialist is key in driving data governance across the regulatory processes and systems. The main purpose of the role is developing the RA data governance operating model to ensure high data quality in RA and across the value chain

 

As Regulatory Data Specialist, you will be engaging with stakeholders across Novo Nordisk and communicating at all levels to ensure a fit for purpose data model and governance. You will be working closely with the data professionals in RA to secure correct maintenance of master data and resolution of data challenges. You will also ensure alignment with external regulatory requirements and you will be driving the IDMP implementation in Novo Nordisk.  

 

This role is an excellent opportunity to make a significant impact, enable data driven regulatory strategies and shape the future of RA.

 

Qualifications

You have 8+ years’ experience from the pharmaceutical industry and Regulatory Affairs. You have a thorough understanding of the RA processes and how data is designed to support these processes; you have knowledge of the data landscape and IT systems across RA stakeholders (e.g. Safety, Clinical, Product Supply) and a great knowledge of the industry standard regulatory data models (IDMP).

 

You have experience and a good knowledge of defining and developing data governance frameworks and how to operationalize data governance to get the desired business outcome.

 

Experience with working in an agile project within the SAFe framework is an advantage.

 

Working at Novo Nordisk

At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and other chronical diseases. We offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

 

Contact

If you want to hear more about the position, contact Sana Moussa +45 3079 2488.

 

Deadline

19 July 2021

Millions rely on us 

At Novo Nordisk, we don’t wait for change. We drive change. 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 experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life changing.