stillingsbetegnelse: Director – Regulatory Affairs, Biopharm

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg Join a fast-changing environment where engaged people do their best every day to obtain and maintain market authorisations worldwide for all Novo Nordisk medicine 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 In the RA Biopharm area we are responsible for all the regulatory activities with clinical and/or labelling impact for Haemophilia, Growth Hormone and Hormone Replacement Therapy (HRT). We are organised in smaller product teams within the department, however we work in a flexible manner according to work load in the different teams. You will work in a fast paced environment with tight deadlines, and you will be supported by friendly colleagues with a good sense of humour. The job As Director for Late stage Haemophilia Products, Hormone Replacement Therapy (HRT) & Oral Anti-Diabetics (OAD) Products you will be responsible for a team of 10 direct reports and a total of 14 products. You will be part of the RA Biopharm management team and you will actively contribute to ensuring that Global RA and Area business processes are effective and up to date with respect to regulatory requirements, effective processes and business needs. You will have direct contact with regulatory authorities, and you must ensure optimal liaison and effective negotiation with major regulatory agencies on behalf of Novo Nordisk and also internally at project portfolio at select portfolio meetings. Qualifications You hold a scientific degree at MSc/PhD level supplemented with postgraduate education in Drug Development, GXP, Regulatory affairs and business understanding. You have a proven track record of extensive global regulatory understanding and experience of supporting product development and delivering product licences. You have experience with working in a global organisation and with developing and delivering regulatory strategies, interpreting commercial strategies and tactical business plans. At the same time, you have extensive experience with negotiating successfully with key regulatory authorities e.g. FDA, EMA, EU national authorities, PMDA etc. Finally, you are fluent in both written and spoken English on a professional level. At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment. Contact For further information, please contact Maria Jose Arce Tomas at +45 3079 1319. Deadline 18 October 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