stillingsbetegnelse:
Senior Regulatory Professional in RA Modern & Human Insulins

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? We are currently looking for a Senior Regulatory Professional with an interest in working with clinical Life Cycle Management (LCM) activities to join our Modern & Human Insulins’ team. About the department The Modern & Human Insulins team is a part of the Regulatory Insulins and Oral proteins department. In the team, we are 10 regulatory associates and professionals working with all the clinical regulatory LCM activities for our marketed modern and human insulin products. The job You will be regulatory responsible for one of our most important modern insulin products. You will drive the clinical LCM activities for this product 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 be expected to prepare meeting packages for authority meetings, conduct rehearsals and participate in the meetings. You will also be supporting the regulatory associate in handling labelling change requests and other 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 a team of friendly colleagues with a good sense of humour. Qualifications We expect you to have a Master degree in science and minimum five years 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 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 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 call Dorte Tingskov at +45 3075 8086. Deadline 28 August 2014.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark