stillingsbetegnelse: Senior Regulatory Professional

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg Join a fast-changing environment where engaged people do their best every day to get Novo Nordisk medicine and devices approved across the globe. 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 place to work – but also quite challenging. Would you like to proactively ensure that development projects meet regulatory requirements, collaborate with your regulatory colleagues worldwide and help find the regulatory path for devices and thus enable our “fast to market” mission? About the department You will be part of the Regulatory Affairs Device group which consists of 25 colleagues, divided into two departments. Here, you will join the RA Durable Devices and Needles department. As globally responsible for supporting the registration of medical devices worldwide, we continuously strive to stay 100% up-to-date with global regulatory requirements regarding regulations. The job As new Regulatory Affairs Professional, you have solid RA, QA or project management experience with medical devices. Other areas that have given you in depth understanding and experience with Novo Nordisk products could also be taken into consideration. The position is two-fold. On one hand, you will follow device development projects from the early phases, providing input and translating complex regulatory issues into valuable information to the project, to ensure the best regulatory strategy. On the other hand, it will be your responsibility to coordinate and plan registrations during life-cycle management authorisation, with the Device/Needle departments in Hillerød and Hjørring as well as support the affiliates with information going beyond the standard regulatory files. As the area is moving into handling and managing more and more complex projects involving several other areas, this position requires talent and independent drive for project management. You will have the unique opportunity to establish a global network working with our affiliates and to enhance your knowledge by participating in a range of development projects manned with highly skilled people – all experts within their field. Qualifications You hold a Master’s degree in Science, Engineering, Pharmacy or other relevant education. Experience within regulations of medical devices and knowledge of international regulatory laws and standards as well as project management will be an asset. It is imperative that you are self-driven, is strategic thinking and able to make the right regulatory decisions – and thus set the regulatory agenda. With proactive approach you are able to bring valuable input and support to the projects. Finally, you are able to communicate complex regulatory issues to a large mix of stakeholders from R&D to production and marketing and have a good knowledge of databases, systems as well as Excel and Outlook. 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. Contact For further information please contact Mette-Marie T. Nøigaard at +45 3079 4462. Deadline 11 August 2015.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark