Regulatory Affairs Lead - late-stage development project

In Global Regulatory Affairs engaged people are committed to gaining regulatory approvals of Novo Nordisk’s medicines across the globe. Our people have a unique combination of scientific insight, patient focus, business understanding, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work.
Apply now for a life-changing career! 

The position 

As Regulatory Affairs Lead - late-stage development project in the RA CagriSema T2D & Amplify department, you will be part of a fantastic team of 13 people. You will work closely with GRL’s, Regulatory Leads and Regulatory Professionals within our department and across our portfolio. 

Your main responsibilities include:
•    You will be responsible for regulatory strategies for the assigned tracks and drive clinical regulatory activities within a large late-stage development project. 
•    You will be a member of cross-functional project and submission teams, and as such, interact with a variety of stakeholders from different departments in Novo Nordisk.  
•    You will as Regulatory Affairs Lead be accountable for bringing regulatory strategic leadership and innovation to the project and proactively contribute to project team decisions  e.g. by forming global regulatory strategies, leading health authority interactions, providing input to clinical and non-clinical development, and coordinating and planning all regulatory activities.
•     You will lead the regulatory activities for the assigned tracks to ensure timely and high-quality regulatory deliverables to the global project teams. 
•    You will work closely with other colleagues, ensure knowledge sharing within- and across projects, and provide sparring and mentoring to others
•    You will report to the Senior Director of RA CagriSema T2D & Amplify and will take active part in department related activities, including improvement projects across Global RA. In addition, you willYou will work in a fast-paced environment with tight deadlines where no two days are alike, and you will be supported by friendly colleagues. 

Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office and on-site work in Soeborg, Denmark where the  department is based.

Qualifications
Your background covers a master’s degree within life sciences with 7+ years of relevant experience and/or PhD with 5+ years of relevant working experience, preferably within pharmaceutical company.

To be successful in this role:
•    You have solid regulatory experience including health authority’s interactions and an all-round understanding of regulatory requirements for drug development.
•     You are driven by science and innovation, can understand complex scientific issues, and will be able to bring them into a regulatory context and display a strategic mindset. 
•    You are well organized and have solid project management skills and problem-solving capabilities.
•    You have strong IT/digital skills and thrive with finding new ways to optimise our work. 
•    Finally, you are a good communicator and are comfortable using your fluent written and spoken English daily. 

As a person you thrive in a busy environment; bring a can-do spirit and a healthy sense of humour to your work – even when the pressure is on. You build effective working relations and are a flexible and change-oriented person who focuses on opportunities rather than limitations in challenging situations. You show curiosity and creativity and can suggest unconventional solutions. 

About the department
In RA CagriSema T2D & Amplify department, we contribute to the Novo Nordisk purpose of driving change to prevent chronic diseases by developing new treatment options for chronic conditions like type 2 diabetes and cardiovascular diseases. We are a team of 13 dedicated and highly engaged GRL’s, regulatory leads and professionals with diverse backgrounds and experiences. We value trust, openness, and innovation in our work. As part of the global development project teams, we are responsible for regulatory strategies and tactics, product labeling, health authority interactions, clinical trial applications, and marketing authorisation applications. We collaborate closely with stakeholders in regions and affiliates and work in global regulatory matrix teams to execute ambitious plans.
Working at Novo Nordisk

At Novo Nordisk, we do not 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, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.

Contact
For further information, please contact Senior Director Eva Lisby Arp-Hansen at +45 3079 0241  

Deadline
Please apply for the position no later than 2 of February 2025

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.