stillingsbetegnelse:
Regulatory Professional in Life Cycle Management Victoza®

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg Join a fast-changing environment where engaged people do their best every day to obtain and maintain market authorisations for all Novo Nordisk medicine, worldwide. Our people have a unique combination of scientific insight combined with the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting place to work – but also quite demanding. Are you up for the challenge? About the department The Regulatory Affairs Victoza® department is located in the Novo Nordisk project house in Søborg. In the Victoza® Life Cycle Management (LCM) team we are nine highly skilled and dedicated people being responsible for all the regulatory life cycle management activities with clinical and/or labelling impact for Victoza® – our blockbuster GLP-1 agonist for the treatment of type 2 diabetes – marketed in more than 100 countries and used by more than a million patients. We are currently looking for a Regulatory Professional, who has an interest in working with Life Cycle Management activities, to join the team. The position As a Regulatory Professional you will drive, coordinate and actively follow-up on clinical life cycle management tasks with demanding and often overlapping timelines. You will lead clinical LCM activities in close collaboration with internal stakeholders, affiliates and health authorities worldwide. You will evaluate LCM ideas and authority requests; as well as plan, prepare, compile and submit documentation to authorities to ensure regulatory approvals. In addition, you will be expected to provide regulatory input, be proactive, challenge the discussions and contribute to project team decisions. You will work closely together with a Regulatory Associate handling labelling change requests and various requests from affiliates and other stakeholders. You will work in a fast paced environment with tight deadlines where no two days are alike, all the while supported by friendly colleagues with good senses of humour. Qualifications You have a Master’s degree in science and some years’ experience working in Regulatory Affairs (or other relevant position in the Pharma industry – e.g. medical writer), preferably handling clinical activities. You have a flair for IT systems. Fluency in written and spoken English is a must. On a personal level, you have good communication, 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, are patient-minded, and you have a strong quality mind-set. You are an active team player, but also enjoy working independently. You have a positive attitude, good sense of humour and are capable of managing busy, changing and sometimes pressure-filled circumstances – all while keeping your spirits high. Working at Novo Nordisk At Novo Nordisk we use our skills, dedication and ambition to help change the lives of people with diabetes. By working with us you will have the opportunity to do the same in a global business environment. Contact For further information Louise Buchholt Johansen can be contacted from 1 August at +45 3079 1381. Deadline 7 August 2016.

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