stillingsbetegnelse: Regulatory Associate

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg Would you like to be part of Novo Nordisk Regulatory Affairs in Søborg? We are seeking a Regulatory Associate to join the CMC Long acting insulins regulatory affairs team. You will work together with a number of highly skilled and motivated people responsible for ensuring the worldwide submissions and approvals in the insulin area. We are looking for a person who enjoys structure, promptness and a dynamic environment. We offer an opportunity to work within an exciting regulatory area. You will collaborate with colleagues from across the Novo Nordisk organisation both in Denmark as well as internationally. About the department Overall, Regulatory Affairs is 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. The RA CMC Long acting insulins area is based in Søborg and consists of 14 people working with projects ranging from early to late stage development, and with marketed products. The job You will be part of a team preparing the regulatory documentation for RA CMC Long acting insulins products for ensuring regulatory approvals. You will assist with the preparation, submission and approval of worldwide applications in close collaboration with our regulatory professionals (academics) and the regulatory project manager. In collaboration with the team you will perform quality check of regulatory CMC documents and submit regulatory files to countries all over the world. At the same time you will coordinate and handle multiple requests from Novo Nordisk affiliates located across the Globe. Regulatory Affairs is a constantly changing environment where tasks and priorities may change from one day to the other. Tight deadlines, cross-departmental and cross-cultural collaboration, and international communication will be part of your normal workday. This requires good coordination and planning skills, accountability and the ability to work under tight deadlines including high work loads 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 internal and external requirements within area of responsibility. The temporary position has a period of one year. Qualifications The perfect candidate has previous experience with regulatory submissions and experience from CMC related activities. As a person you thrive in busy environments and you bring a can-do spirit and a healthy common sense and a sense of humour to your work – even when the pressure is on. You are a strong team player, but you also enjoy working independently. You are well organised, a good planner and a proactive problem-solver, who are able to collaborate with a lot of stakeholders. You’re also a skilled communicator who is comfortable speaking and writing in English. You have a flair for IT systems and experience with MS Office. 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 Dorrit Espersen Juul at +45 3075 8242. Deadline 22 May 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