Do you dream of a career with a global pharmaceutical company built on life-changing innovative investigational medicines and devices? Does working with highly talented and engaged colleagues from many different professional backgrounds and cultures inspire you?
 
Then you could be our new RA expert within stem cell therapy product development in the RA Device department and you will get a unique opportunity to establish a global network at Novo Nordisk, and to enhance your knowledge by participating in innovative drug-device combination product projects involving highly skilled people – all experts within their field. The position
This position is newly created with the purpose of ensuring close collaboration with research unit on development of future solution for treatment of serious diseases. You will be involved with the R&D teams from the start, working closely with colleagues across the organization.
Your Regulatory expertise within the field of class III Devices is needed to determine the Regulatory strategy and maintain dialogue with authorities and support the projects as well as the affiliates. You will be part of the core team leading key activities from early development through to clinical trials and up to marketing applications. You will be responsible for interacting with health authorities and submitting regulatory files to ensure product approval.
Most importantly, you will have the possibility to influence your role according to your interests and specialization.
Your main responsibilities will be focused on:
• In conjunction with Medical Device, Combination Products and Manufacturing and Controls (CMC) Regulatory colleagues, supporting submission strategies leading to clinical trial and marketing approval of complex cell/device combination products
• Communicating with other departments to support regulatory submissions, provide global input to teams for submission requirements
• Reviewing cross-functional submission deliverables for key geographies including US, EU, Japan, Canada, and others. This will include feedback on optimization of device labeling, familiarity with relevant standards and GSPR inputs, and feedback into design and risk documentation
• Supporting medical device meetings with regulators
• Being a key representative on a core team providing regulatory strategy guidance interpreting current regulatory health authority expectations to stem cell project teams
• With RA colleagues, manage interdependencies between device, cell drug product, and formulation. Qualifications
The ideal candidate has:
• At a minimum, a bachelor’s degree in a science or technical discipline
• EU Medical Device Regulation experience within class III and knowledge of international legislation and standards
• Extensive RA experience working in development including clinical studies for devices, combination products, or pharmaceuticals.
• Project management skills will be an advantage
• An RAC (Regulatory Affairs Certification) device or drug credential and/or experience in international legislation, standards and a well-rounded functional perspective is a bonus
• RA experience within the field of ATMP is desirable
On a personal level, this role requires outstanding communication abilities and a proactive, solution-oriented mindset. Proficiency in providing guidance and mentorship to colleagues and excellent planning and coordination skills to handle complex tasks are also essential attributes. About the department
RA Device is part of the RA CMC & Device Area in Novo Nordisk. We are responsible for submission planning including applying intelligence and develop regulatory strategy for the medical device and device constituent of drug-device combination projects, to ensure minimum time to market and thus patients. This includes evaluating applicable guidelines, requirements and using external relations and network in your day-to-day work, as well as planning and conduct of regulatory interactions with health authorities.
 
Regulatory Affairs is a truly multi-disciplinary department with high professional standards and excellent opportunities for fast-paced professional development and career progression. As part of the RA team, you cooperate closely with a wide range of stakeholders including Stem Cell Research Unit RA, Device R&D, Production, Marketing, Clinical Drug Development, and other functions.
The Cell Therapy R&D team is focused on developing cellular medicines that have the potential to change the way doctors treat intractable diseases. You will have the chance to support a dynamic, innovative, and interdisciplinary team focused on developing the combination products that enable preparation and delivery of these novel cell products.
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, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information please contact Lykke Forchhammer at +45 3075 1356.
Deadline
31 January 2024.
Applications will be evaluated continuously when received and candidates may be called for interview before the deadline.
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.