Global Regulatory Lead

Category:  Regulatory
Location: 

Søborg, Capital Region of Denmark, DK

   

Join Regulatory Affairs and become a part of an exciting environment where 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.


About the department
In RA (Regulatory Affairs) Diabetes and Obesity II department we are responsible for progressing innovative projects aiming at the development of new treatments for diabetes, including novel insulins, gene therapy for prevention of diabetes, and new in-class innovative insulin delivery systems. We work as an integrated part of development and research project teams and cross-functional sub-teams. We are twelve dedicated and highly engaged employees reporting to the Senior Regulatory Affairs Director. 


The position
We are looking for a Global Regulatory Lead with a strong interest in science and innovation to lead regulatory strategies and activities on early projects. You will be responsible for regulatory strategies for innovative projects including gene therapy treatment for the prevention of diabetes and innovative project testing first-in-class devices for insulin delivery 
You will be a member of the Global Project Team (GPT) and bring innovation to the projects 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 matrix team to ensure timely and high-quality regulatory deliverables to the global project teams. 


Qualifications
We expect you to have a Master of Science (life sciences) with 5-8 years of relevant experience, and/or PhD (preferably) with 3-5 years of relevant working experience (e.g., regulatory sciences, clinical and non-clinical drug development, medical writing, clinical trial management). You are driven by science and innovation, can understand complex scientific issues, and will be able to bring them into a regulatory context. As a person you thrive in a busy environment; bring a can-do spirit and a healthy sense of humor to your work – even when the pressure is on. You are a flexible and change-oriented person who focuses on opportunities rather than limitations in challenging situations.


Working at Novo Nordisk
At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. 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
For further information, please contact Magdalena Jayatissa + 45 30 79 49 42


Deadline
October 23, 2022, but we will invite for interviews on ongoing bases 

 

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.