Arbejde Regulatory Professional Hovedstaden NOVO NORDISK A/S - jobtilbud

GÆLDER
stillingsbetegnelse: Regulatory Professional

jobbeskrivelse:
Regulatory Affairs Denmark - Søborg Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring rapid regulatory approval in all our markets. Regulatory Affairs is a fast-changing field, and the dedicated employees in our unit need both keen negotiating skills and scientific insight to serve as Novo Nordisk’s advocates around the world – and make a meaningful difference to our business. About the department In our department, consisting of 9 dedicated colleagues, we are responsible for all global regulatory CMC activities on early diabetes and obesity projects, Glucagon®, s.c. semaglutide, liraglutide Obesity and Victoza®. The premises for the department is a matrix structure where close collaboration with all departments is a prerequisite for success - so this is what we do. The job Not two days will be alike. We expect you to make an impact in order to ensure successful regulatory results for Victoza® worldwide. You will work and grow within an exciting area, where interaction in cross-functional teams, working closely with colleagues in other departments and in Novo Nordisk affiliates outside Denmark, will be part of your working day. Ýou will experience ongoing changes in your projects, tight deadlines, cross-departmental collaboration, and the challenges of international communication, which will require you to adapt. Your key focus will be on securing regulatory compliant CMC documentation supporting Victoza®. Together with scientific experts in the organisation, you will be responsible for the quality of documentation submitted to health authorities and you will ensure compilation of high quality regulatory dossiers. Overall, you will be responsible for regulatory CMC submissions and approvals to ensure we are in compliance with Victoza® licences worldwide with respect to optimal production processes and the conduct of clinical trials. Qualifications You have a university degree in science and documented professional experience working with regulatory affairs and/or the pharma industry. As a person, you thrive in busy environments and bring a can-do spirit and a healthy sense of humour to your work – even when the pressure is on. You’re a strong team player, but you also enjoy working independently to challenge the status quo and find new solutions to the challenges you meet. You’re also a skilled communicator who is comfortable speaking and writing in English. You have experience working with CMC from your current or earlier job, either within Regulatory Affairs or in other parts of the organisation. At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and more than 371 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference Contact If you have any questions at all about the position or about Novo Nordisk Regulatory Affairs, please don’t hesitate to call Dennis B. Hansen on +45 30 75 15 67. Deadline 11 June 2014.

Arbejdsgiver Navn: NOVO NORDISK A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse:
Arbejde, der forudsætter viden på højeste niveau inden for pågældende område

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark

GÆLDER

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