stillingsbetegnelse: Department Manager for RA CMC Haemophilia

jobbeskrivelse:
- Regulatory Affairs - 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. Are you on the lookout for the opportunity to combine your scientific understanding, regulatory insight, and leadership skills? About the department At Novo Nordisk Regulatory Affairs (RA), we strive to make new and better medicines available worldwide, for among others people with diabetes and haemophilia. In the haemophilia area we are supporting three haemophilia products on the market (NovoSeven®, NovoEight® and NovoThirteen®, two new haemophilia drugs in phase 3 extensions and a strong pipeline of early haemophilia projects. The job As Department Director your primary focus is to manage the growing pipeline of haemophilia products and projects. The main focus will be to ensure approval of our new long-acting FIX product, the continuous approval process of NovoEight® and NovoThirteen® in selected countries, and the maintenance of our NovoSeven file. Our organisation is dynamic, with change management being an integral part of our everyday life. The job puts high demands on your leadership skills in terms of performance management and your ability to develop a staff of 15 direct reports on the basis of individual and business needs. You secure the quality of the documentation submitted to health authorities, and in this respect will be supported by Regulatory Project Managers, professionals, and associates in our organisation. You report to the Vice President for RA CMC Biopharmaceutics and are a member of the Area’s line management team that is responsible for organisational and staff matters, including the optimising of resources across the Area. You will also be member of the wider Project management team together with our US based colleagues driving the regulatory progress of our portfolio in the US. In addition, you will be involved in cross functional projects and improvement initiatives within and outside the RA organisation, as well as collaboration with Product Supply, CMC Supply, Global Research Unit, and Quality Assurance departments. Qualifications We expect you to have a university degree in science and a proven record of extensive global regulatory understanding and experience, successful liaison with regulatory authorities, profound understanding of haemophilia or other rare diseases, as well as cross-organisational experience in global drug development. You have documented leadership experience: you set direction, lead and motivate your staff to work for joint objectives. As a person you are well organised and have solid problem-solving capabilities, just as you show a winning attitude and never lose your strategic focus. You can keep your spirits high even when under pressure, and as a skilled communicator you can cooperate at any organisational level. Finally, you are comfortable using your fluent written and spoken English on a daily basis. At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and haemophilia change their lives. By working with us you will have the opportunity to do the same in a global business environment. Contact For further information, please contact Torben Storgaard Guldberg on +45 3075 6124. Deadline 6 February 2015.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse:
Arbejde inden for biologi, botanik, zoologi og beslægtede områder

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark