stillingsbetegnelse: Regulatory Associate in RA CMC Insulin

jobbeskrivelse:
•Regulatory Affairs •Denmark - Søborg 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 Insulin and Oral Proteins department is situated in the Novo Nordisk project house together with other regulatory affairs functions in Søborg. We are a group of 33 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 department is organised into four teams. We are currently looking for a Regulatory Associate to join our CMC Insulin team of 12 colleagues. The job The CMC Insulin team is responsible for life cycle management of the marketing authorisations pertaining to the Novo Nordisk marketed insulin products, including human insulin and modern insulin products. In this way, the team 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 for negotiating and reporting 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. In addition, submission plans are developed and strategies are laid down to ensure fast and smooth regulatory approvals. As a regulatory associate you will assist in preparing documentation for health authorities, handle requests from stakeholders and affiliates, provide administrative support to the team, handle various IT systems for archiving of documents and be responsible for compiling input to master plans and reports. You will be responsible for managing data for our registration system and assist in the preparation, submission and approval of worldwide regulatory applications in close collaboration with your colleagues. 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. You will report to the Team Leader of the CMC Insulin Team. Qualifications You have an educational background such as pharmaconomist, B.Sc. in English or similar. You preferably have experience from working in regulatory affairs. You have a flair for IT systems and experience with MS Office applications. You write English at business level and are comfortable speaking English on a daily basis. You are organised, a good planner and have a quality mindset. You have drive and keep your spirits high also under pressure. You are a team player and can also work independently. 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 call Jens Bjørn Nielsen on + 45 3075 6120. Deadline 30 June 2014

Arbejdsgiver Navn: NOVO NORDISK A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark