stillingsbetegnelse:
Regulatory Associate in Regulatory Affairs (maternity cover)

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg Join a fast-changing environment where engaged people do their best every day to obtain and maintain market authorisations worldwide for all Novo Nordisk medicine 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. Are you up for the challenge? About the department Regulatory Affairs Oral Glucagon Like Peptide 1 (GLP-1) & Early Diabetes Projects are responsible for development projects within treatment of diabetes and diabetic complications. We are six dedicated and highly engaged employees working in the department. We work as an integrated part of the global development and research project teams and cross-functional sub-teams. We are responsible for the regulatory strategy and provide regulatory expertise and tactics to the product development plan. We drive label development, Health Authority interactions and clinical trial applications. We have a strong collaboration with our affiliates and work in global regulatory teams. We are currently looking for a Regulatory Associate with regulatory experience to support our activities related to clinical trial submissions and approvals and interactions with Health Authorities. The position We are looking for a person who enjoys structure, promptness and a dynamic environment. You will collaborate with colleagues from Novo Nordisk in Denmark as well as with affiliates. Part of your everyday work will include quality check of documents for regulatory submissions, and compiling and archiving of electronic documents into our global document management system. Administrative duties and IT systems support will be part of your everyday task. We work with several very different submissions and thus you need to be able to joggle several tasks at the same time. The job requires 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 area of responsibility. This vacant temporary position is for Maternity cover of 12 months duration. Qualifications You have a relevant educational background, as minimum a bachelor’s degree in science, business administration or English. Preferably, you should have administrative experience from regulatory affairs or related fields in the pharmaceutical industry and with professional use of IT systems such as electronic document management. You are proficient in the Microsoft Office package. 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. Working at Novo Nordisk At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development. Contact For further information, please contact Vibeke Hatorp on +45 3075 5697. Deadline 8 May 2016.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Revisions- og regnskabscontrollerarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark