stillingsbetegnelse: Regulatory professional

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg Join Regulatory Affairs and become part of a fast-changing environment where engaged people do their best every day to get Novo Nordisk’s medicines approved across the globe. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting place to work – but also quite challenging. We are currently looking for a Regulatory Professional with an interest in working with clinical Life Cycle Management (LCM) activities to join our Modern & Human Insulins department. About the department In the Modern and Human Insulins department we are 13 dedicated employees being responsible for all the regulatory LCM activities with clinical and/or labelling impact for the modern insulin products (Levemir®, NovoRapid® and NovoMix®) and human insulin products, marketed worldwide and used by millions of patients. We are organised in smaller product teams within the department, however we work in a flexible manner according to work load in the different product teams. The job You will be responsible for driving the clinical LCM activities for one of our products in close collaboration with internal stakeholders, affiliates and health authorities worldwide. Driving the clinical LCM activities means being responsible for regulatory evaluation of LCM ideas and authority requests, chairing cross-functional submission teams, planning, preparing, compiling and submitting documentation to authorities and ensuring regulatory approvals. You will work closely together with a Regulatory Associate handling labelling change requests and various requests from affiliates and other stakeholders. You will work in a fast paced environment with tight deadlines where no two days are alike, and you will be supported by friendly colleagues with a good sense of humour. Qualifications We expect you to have a Master’s degree in science and some years of experience from working in Regulatory Affairs in the Pharma industry, preferably with clinical regulatory activities. You have a flair for IT systems and experience with MS Office applications. Fluency in written and spoken English is a must. On a personal level, you have good communication, project management and negotiation skills. You also have strategic skills which you can combine with your ability to understand technical and operational challenges. You work according to high ethical standards and with the patient in mind, and you have a strong quality mind-set. You are a team player, but you also enjoy working independently. You have a positive attitude, good sense of humour, and you thrive in busy and changing circumstances, keeping your spirits high also under pressure. 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 call Dorte Tingskov at +45 3075 8086. Deadline 17 January 2016.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark