Are you passionate about ensuring regulatory compliance and patient safety? Do you have experience in regulatory affairs and quality? Join our team as a Regulatory Lead at Novo Nordisk Ireland and make a difference in the lives of patients. Read more and apply today for a life-changing career.

 

The Position

One of the main tasks in this role would be supporting the regulatory activities and the maintenance of the Novo Nordisk Quality Management System (QMS) in the Irish affiliate. The overall purpose of the role is to ensure product quality, regulatory compliance and patient safety with a focus on business-critical issues that may have an impact on our license to operate and inspection readiness. 

Among your main responsibilities will be:

 

•Support all regulatory affairs activities for Novo Nordisk medicinal products and medical devices on the Irish market
•Lead assigned regulatory projects, launches and initiatives for the Irish market
•Ensure high quality compliant labelling for all marketed products
•Ensure timely updates of critical systems
•Act as a back up to the Quality Lead role: Assist with ensuring that the QMS in the affiliate is maintained and in compliance with Novo Nordisk requirements and external requirements

Qualifications

•3rd level qualification, preferably graduate in Life Sciences
•Relevant industry experience in a similar role: previous regulatory and/or quality experience desirable
•Knowledge of regulatory approval processes and affiliate quality management activities
•IT proficient and previous experience is using regulatory and quality databases
•Excellent written and verbal communication skills
•Effective project management, time management, organisation and prioritisation skills

About the Department

You will join the Regulatory Affairs, Safety & Quality team at Novo Nordisk Ireland. Our small, dedicated team is committed to ensuring regulatory compliance and patient safety. We work closely together in a fast-paced and dynamic environment to support the regulatory activities and maintain the quality management system. Located in Dublin, Ireland, our team plays a crucial role in safeguarding patients and ensuring the availability of our products.

 

Working at Novo Nordisk 

We are a proud life-science company, and life is our reason to exist. We’re inspired 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 research, 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.

 

Application support 

We are an equal opportunities employer, and we commit to an inclusive recruitment process and equality of opportunity for all our job applicants. If you're a person with a disability, if you're neurodivergent, and need any adjustments to be made during the application and selection process, please send an email to Gitte, gifj@novonordisk.com.  Please include your name, the role you are interested in and the type of adjustment your need.
 
Contact 

We can’t accept directly sent CVs, please submit your application via the “Apply” Button. 

 

Deadline 

Apply before 12 February 2025.

 

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.