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 of 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 The RA Biopharm area is situated in the Novo Nordisk project house together with other Regulatory Affairs functions in Søborg. We are part of a group of 30 highly skilled and dedicated people involved in every clinical aspect concerning the regulatory files and licenses, as well as providing regulatory input during the various phases of drug development. We work very closely with our stakeholders within Novo Nordisk headquarters, like Drug Safety, Medical Affairs and Marketing, but also with our affiliates and health authorities around the world. Currently we are looking for a Regulatory Professional to join Hormone Replacement Therapy (HRT) Team, working primarily with the Product Information and other clinical aspects. The job The HRT team is responsible for Life Cycle Management of the marketing authorisations pertaining to the Novo Nordisk marketed 8 HRT products. In this way, the team is responsible for maintaining regulatory clinical compliance by providing assessment of the regulatory impact of changes coming from health authorities, safety issues or product development. As a regulatory professional, you are responsible for planning, coordinating and submitting variation applications and to provide regulatory input in the cross functional projects you are involved in. On a daily basis, you will support affiliate offices in responding to requests from authorities and affiliates and reviewing the documentation needed for submission. You will review and assess change requests and non-conformities and play a role in ensuring work processes are working smoothly and optimally. You will work in a fast-paced environment with tight deadlines, cross-departmental collaboration and deal with the challenge of international communication. You will be expected to make an impact and to ask questions and challenge the status quo if needed. The atmosphere is informal and good humour is always welcome. Qualifications Preferably experience from a Regulatory Affairs position, and knowledge of the MRP/DCP procedures and/or labelling. You are organised, a good planner and exhibit drive. You show a winning attitude and keep your spirits high even when under pressure. You are a team player but can also work independently. For this position you have a master in pharmaceutical science, biology or in an equivalent life-science area. 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 For further information, please call Poul Jacobsen at +45 3079 4882. Deadline 30 November 2015.

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