stillingsbetegnelse: Regulatory Professionals

jobbeskrivelse:
- Research & Development - Denmark - Søborg Join a fast-changing environment where engaged people do their best every day to get Novo Nordisk medicine 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 (RA) a truly interesting place to work but also quite challenging. About the Department The RA Lira Obesity Clinical Department is located in the Novo Nordisk project house in Søborg. We are a group of 11 highly skilled and dedicated people involved in the life-cycle management of Saxenda and the development of our early stage obesity projects. Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring rapid regulatory approval in all our markets. Regulatory Affairs is a fast-changing field, and the dedicated employees in our unit need both negotiating skills and scientific insight to serve as Novo Nordisk’s advocates around the world and make a meaningful difference to our business. We are currently looking for a Regulatory Professional with a science background combined with regulatory experience to join our team responsible for the life cycle management activities of Saxenda. 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 including study groups and submission teams, and as such, interact with a variety of stakeholders from different departments in Novo Nordisk. You will participate in review of clinical trial protocols and reports as well as development of regulatory documentation for submission to health authorities, including briefing packages for meetings with health authorities, clinical trial applications, safety reports, regulatory files for marketing authorization and initiate Life Cycle Management activities. You will be expected to provide regulatory input, be proactive, challenge the discussions and contribute to product team decisions. Qualifications You have a Master of Science, or similar, and a proven record of global regulatory understanding and experience. Project management experience is a plus, but not required. You are organised, a good planner and a proactive problem-solver, and you’re a skilled communicator who is comfortable speaking and writing in English. As a person, you thrive in busy environments and bring a can-do spirit and a healthy sense of humour to your work even when the pressure’s on. You’re a strong team player, but you also enjoy working independently. We create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and close to 366 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference. At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. Contact For further information, please Contact Christina Balslev Rindshøj at +45 3075 9092. Deadline 18 June 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