stillingsbetegnelse:
Senior Regulatory Professional for Long Acting Insulins

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 Senior Regulatory Professional with an interest in working with life cycle management activities to join our Long Acting Insulins department. About the department In the Long Acting Insulin Products department we are responsible for regulatory development and Life Cycle Management (LCM) activities with non-clinical, clinical and/or labelling impact for Tresiba®, Ryzodeg® and other insulin development projects. We are currently looking for a Senior Regulatory Professional to join our department of 12 dedicated employees. The position As Senior Regulatory Professional you will drive the clinical submission activities for one of our products in close collaboration with internal stakeholders, affiliates and health authorities worldwide. This means driving clinical LCM activities by 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 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 humor. Qualifications We expect you to have a Master’s degree in science and at least 5 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 humor, and you thrive in busy and changing circumstances, keeping your spirits high also under pressure. We will conduct interview on a ongoing basis so please send your application as soon as possible, but no later than 12 July 2016. 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 call Jane Møll Pedersen at +45 3075 3759. Deadline 26 July 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