stillingsbetegnelse: Senior Regulatory Associate

jobbeskrivelse:
- Administrative - Denmark - Søborg Our growth is your opportunity Being part of Novo Nordisk Research & Development means working at one of the world's largest and most successful biopharmaceutical companies. Our R&D organisation is vital to Novo Nordisk's continued growth and we always welcome talented people who would like to grow with us. In this position you will contribute to changing possibilities in haemophilia. If you find this inspiring, and if you have knowledge or experience from compiling applications for new drug products, then you may just be the regulatory associate we are looking for. Novo Nordisk Regulatory Affairs (RA) makes medicine available to patients all over the world by obtaining and maintaining market authorisation worldwide. Regulatory Affairs is a fast-changing field, and the dedicated employees in our unit serve as Novo Nordisk’s ambassadors around the world. About the department The RA CMC Haemophilia area is based in Søborg and consists of 16 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 a haemophilia product 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 your 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. Qualifications The perfect candidate has previous experience with major 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 we encourage our employees to make the most of their talent, and we reward hard work and dedication with the opportunity for continuous learning and personal development. Contact For further information, please call Hanne Henriksen on +45 3075 9061 or Torben Storgaard Guldberg on +45 3075 6124. Deadline 10 December 2014.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Arbejde inden for samfundsøkonomi

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark