stillingsbetegnelse: Regulatory Professional

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg Our growth is your opportunity Being part of Novo Nordisk Research & Development means working at one of the world's largest and most successful biopharmaceutical companies. Our R&D organisation is vital to Novo Nordisk's continued growth and we always welcome talented people who would like to grow with us. Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring rapid regulatory approval in all of our markets. Regulatory Affairs is a fast-changing field, and the dedicated employees in our unit need both keen negotiating skills and scientific insight to serve as Novo Nordisk’s advocates around the world – and make a meaningful difference to our business. About the Department The RA CMC Human and Modern Insulin department is situated in the Novo Nordisk project house together with other regulatory affairs functions in Søborg. We are a group of 14 highly skilled and dedicated people involved in every CMC aspect concerning the regulatory files and licenses, as well as providing regulatory input during the various phases of drug development. We work very closely with stakeholders within Novo Nordisk headquarters, manufacturing sites outside Denmark, our affiliated offices and health authorities around the world. The Job The CMC Human and Modern Insulin department is responsible for life cycle management of the marketing authorisations of Novo Nordisk marketed human and modern insulin products as well as new products within the therapeutic area. The department is responsible for maintaining regulatory compliance by providing assessment of the regulatory impact of changes made in the production to the manufacturing of the insulin products, and as relevant negotiate and report these changes to health authorities globally. The team is working closely with production as well as our affiliate offices in making regulatory documents and dossiers of high quality for global submissions. As a regulatory professional, you are responsible for planning, coordinating and submitting variation applications and to provide regulatory input in the cross functional projects you are involved in. On a daily basis, you will support affiliate offices in responding to requests from authorities and reviewing the documentation needed for submission. You will review and assess change requests and non-conformities and play an important role in ensuring work processes are working smoothly and optimally. You will work in a fast-paced environment with tight deadlines, cross-departmental collaboration and deal with the challenge of international communication. The atmosphere is informal and good humour is always welcome. Qualifications You have a university degree in science and documented professional experience from a regulatory affairs position and/or the pharma industry. You are organised, a good planner and exhibit drive. You show a winning attitude and keep your spirits high even when under pressure. You are a strong team player and can also work independently. You are fluent in speaking and writing in English. 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 Astrid Spillum +45 3075 4014. Deadline 16 March 2015.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Arbejde inden for samfundsøkonomi

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark