(Senior) Regulatory Professional in RA Submission Systems

Do you want to be part of an exciting environment? Would you like to have the opportunity to transform the way Regulatory Affairs operates? We are looking for a Regulatory Professional who comes to work every day looking for opportunities for improvement and to drive changes. Apply now for a life-changing career! 

The position 

The (Senior) Regulatory Professional in RA Submission Systems is key in driving the continuous optimisation of the submission and registration processes in the system Vault RIM, triggered by evolving business needs and the three yearly releases from the vendor Veeva. The main purpose of the role is to impact processes and solutions while ensuring business value via smooth adoption in the organisation.

As a (Senior) Regulatory Professional in RA Submission Systems at Novo Nordisk, you will: 

• Ensure evaluation, prioritisation, implementation, communication, and training in new Vault RIM features across Global Regulatory Affairs. 
• Support and drive Vault RIM process development and optimisation. 
• Engage with stakeholders and external vendors, providing technical guidance and regulatory input to ensure fit-for-purpose processes and solutions. 
• Guarantee alignment with external regulatory requirements. 

Qualifications 

To be a competitive candidate, you should have: 

Need to have: 

• A master’s degree in a relevant field, such as science, pharmacy, or equivalent. 
• At least 3+ years of experience in the pharmaceutical or other similar industry, preferably within Regulatory Affairs. We are open to different levels of seniority. 
• Strong understanding of overall business processes, an analytical and quality mindset, and a flair for IT. 
• Fluency in English, both written and spoken. 

Nice to have: 

• Experience in working with Vault RIM or a similar Registration Information Management system. 
• On a personal level, you are curious to learn, well-organised, a multitasker and a proactive problem solver. You enjoy working in a diverse and global team and are good at communicating complex ideas clearly, effectively and with impact to enable business decisions. You thrive in an environment with changing circumstances and have a can-do attitude as well as a healthy sense of humour. 

About the department 

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. In this role, you will have the unique opportunity to be part of a strategically crucial business transformation programme across multiple processes and geographies and take an active part in shaping the way Regulatory Affairs will work in the future. 

You will join RA Submissions Systems. The department consists of 16 Professionals and Specialists located in Denmark and India. In this position, you will get the opportunity to join our team in Denmark. Our aspiration is to ensure that Vault RIM is used in an optimal manner, identifying business needs in the Submission and Registration process and leveraging digital solutions and automations to the benefit of our regulatory purposes. The atmosphere in the department is informal, and our commitment to innovation also applies to the way we work. We embrace a flexible workplace, with a blend of in-office and remote work. 

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 experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing and sales – we’re all working to move the needle on patient care.

Contact 

For further information, please contact Associate Director, RA Submission Systems, Anette Schøndorff Enggaard at [email protected] or get to know us better by visiting www.novonordisk.com/careers.  

Deadline 

2nd of March 2025 

Applications will be evaluated continuously when received, and candidates may be called for an interview before the deadline. 

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. 

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.