Regulatory Associates

Aufgabenbereich:

- Administrative - Denmark - Søborg Would you like to be part of Novo Nordisk Regulatory Affairs and part of “can-do” department located in Søborg, Denmark? If yes, then we are seeking a Regulatory Associate for the Saxenda® product. About the department Regulatory Affairs is an area within Global Research and Development, responsible for obtaining and maintaining marketing authorisations worldwide. This includes interaction with Health Authorities in connection with planning of meetings, submission of clinical trial applications, submission and maintenance of marketing authorisation applications. You will work together with a highly skilled and motivated team responsible for ensuring new marketing authorisation of Saxenda® around the world and maintaining already obtained approvals. The job As Regulatory Associate it is your responsibility to ensure the quality of our documents for our regulatory submission. You will be working in close cooperation with the Global Regulatory Lead on the management of the Global Regulatory Team. You will also be responsible for compiling and archiving of electronic documents into our global document management system and administrative duties and IT systems support will be part of your everyday tasks. You will be working on several different tasks at once and it is important that you can keep your high spirits even under pressure. You will be working independently and good coordination and planning skills, accountability and the ability to work under tight deadlines including high workloads in periods. You will be a key player in keeping track of timelines and deliverables. You will also be responsible for keeping up to date with current requirements within your area of responsibility. Qualifications You have an educational background as pharmaeconomist, medical secretary, bachelor in science, marketing, English or similar. You have a flair for IT systems and experience with MS Office applications as you will be responsible for managing data entry and electronic filing in our various databases and document management systems. Fluency in written and spoken English is a must. You are proactive and like to work independently, as well as in a team. You are flexible, are able to work under tight deadlines, have a strong quality mindset and a sense for details, good coordination and planning skills and an excellent command of written and spoken English. Contact For further information, please contact Christina Balslev Rindshøj on +45 30 75 9092. Deadline 12 February 2016.

Arbeitszeit:

• Ohne Arbeitszeitbestimmung
  

Anforderungen

source: https://www.ec.europa.eu/eures

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