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Regulatory Specialist in RA NextGen Drug-Device

Join a fast-changing environment where engaged people do their best every day to get Novo Nordisk medicines and devices approved globally. We are expanding the development of products in the exciting interface between CMC and device to deliver innovative products to our patients. Our people have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work.

About the department
The RA NextGen Drug-Device department is part of the Regulatory Affairs CMC & Device Area.

In RA NextGen Drug-Device we are responsible for the device aspects of the regulatory process to obtain approvals for our new innovative biologic and drug device combination projects globally. This is achieved by developing and implementing strategies based on current legislation and regulations and negotiating with authorities to ensure minimum time to market.

As part of RA NextGen Drug-Device you cooperate closely with a wide range of stakeholders including Device R&D, Production, Marketing, Medical & Science and Affiliates. To ensure full integration with the projects the RA specialist is also embedded in the project and regulatory matrix teams. 

The job
Novo Nordisk is evolving its portfolio in drug-device combination product development across an exciting array of innovative products, including biopharmaceuticals and new delivery systems. You will be involved with the R&D development teams from the start. Working closely with colleagues across the organisation and leading key activities from early development though 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. Your regulatory expertise is needed to determine the regulatory strategy, establish and maintain dialogue with authorities and support the projects as well as the affiliates.

You will get a unique opportunity to establish a global network and to enhance your knowledge by participating in innovative drug-device combination product projects involving highly skilled people – all experts within their field. Furthermore, you will get the opportunity to participate in advocacy groups both internally and externally in close collaboration with our RA Policy & Intelligence group.

Most importantly, you will have the possibility to influence your role according to your interests and specialization.

Qualifications
You hold a master’s degree in Science, Engineering, Pharmacy or other relevant education and you have minimum 8 years of relevant experience working with regulations in CMC or drug-device combination products. Knowledge of international legislation and standards, experience from the pharmaceutical industry as well as project management will be an advantage.
 
It is imperative that you are self-driven, have a strategic mind-set and able to make the right regulatory decisions – and thus drive the regulatory agenda. With a proactive and innovative approach, you are able to bring valuable input and set the strategic direction for the project(s). Finally, you can communicate complex regulatory topics to many different stakeholders from R&D to production and marketing.

You are fluent in written and spoken English, have strong communication skills and you bring a can-do attitude.
 
At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.


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