stillingsbetegnelse: Regulatory Associate

jobbeskrivelse:
- Administrative - Denmark - Søborg We are currently looking for a maternity leave substitute for one of our associates as of 01-Nov-2014. In this position you will contribute to changing possibilities in diabetes. Novo Nordisk Regulatory Affairs (NNRA) makes medicine available to patients all over the world by obtaining and maintaining market authorization worldwide. Regulatory Affairs (RA) 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 Degludec Drugs area is based in Søborg and consists of 33 people working with both projects ranging from early to late stage development, and with marketed products. The job You will assist with the preparation, submission and approval of worldwide applications in close collaboration with our regulatory professionals (academics) and project managers. You will be a part of a team focusing on maintaining the marketing authorization for Tresiba® and Ryzodeg® and for ensuring approvals in new markets. Your main focus will be on the clinical part of the regulatory process. In collaboration with your team you will perform quality check of regulatory clinical documents and submit regulatory files to countries all over the world. At the same time you will be involved in document control and archiving. 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 We expect you to have a Bachelor degree preferable in natural science (e.g. Laboratory Technician, Pharmacy Technician or Nurse). Experience working with regulatory affairs and/or from clinical related activities is preferable. As a person you thrive in busy environments and you bring a can-do spirit, 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. If you find this inspiring, then you may just be the regulatory associate we are looking for. 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 Jane Møll Pedersen on +45 3075 3759. Deadline 10 September 2014.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Job kort beskrivelse:
Teknikerarbejde inden for kemisk og fysisk videnskab

land: Danmark

region: Hovedstaden

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark