stillingsbetegnelse:
Regulatory Professional in RA Fast Acting Insulin Projects

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg Join 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 and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting place to work – but also quite challenging. Are you up for the challenge? About the department We are a team of 7 highly engaged specialists working with late stage development project aiming at development of new generation of mealtime insulin analogues. We are currently looking for a Regulatory Professional with science background combined with regulatory experience to support our activities related to global development of new insulin analogue. The job As a Regulatory Professional you will be required to drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines. You will be a member of cross functional project teams and as such, interact with variety of stakeholders from different departments in Novo Nordisk. You will also be a member of a global regulatory team and work closly with collegues from regulatory departments across the world. You will participate in a development of regulatory documentation for submissions to health authorities worldwide. This will include preparation of briefing packages for meetings with health authorities, clinical trial applications, safety reports and regulatory dosiers for marketing authorization. You will be expected to provide regulatory input, be proactive, challenge the discussions in crosfunctional teams and contribute to project team decisions. You will work in a fast paced environment with tight deadlines where no two days are alike. Qualifications We expect you to have a master degree in scientific discipline and experience from working in Regulatory Affairs. 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 project management and communication skills. You also have analytical skills with the ability to focus on detail without losing the overview. You work according to high ethical standards and 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 keep your spirits high also under pressure. At Novo Nordisk we strive for excellence. As a world leader in in diabetes care and a major player in haemostasis and hormone replacement therapy, we offer our employees opportunities for continuous growth. Contact For further information, please contact Magdalena Jayatissa at +45 3079 3647. Deadline 16 November 2015.

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