stillingsbetegnelse:
Senior Regulatory Professional - Life Cycle Management

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 The Regulatory Affairs Victoza® department is located in the Novo Nordisk project house in Søborg. In the Victoza® 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 Senior Regulatory Professional with a science background combined with regulatory experience to join our team. In collaboration with experienced regulatory professionals and associates you will be responsible for clinical life cycle management activities within the project. The job As a Senior Regulatory Professional you will drive, coordinate and actively follow-up on clinical life cycle management tasks with challenging and often overlapping timelines.You will drive clinical LCM activities in close collaboration with internal stakeholders,affiliates and health authorities worldwide. You will evaluate LCM ideas and authority requests, chair cross-functional submission teams,plan,prepare,compile and submit documentation to authorities and ensure regulatory approvals.You will be expected to provide regulatory input,be proactive,challenge the discussions and contribute to project team decisions.You will play an important role in the team, and it is expected that you can take up a senior role and pro-actively contribute to the shared agenda.You will work in a fast paced environment with tight deadlines where no two days are alike.You can look forward to a job in a well-functioning team where you will be supported by friendly colleagues with a good sense of humour. Qualifications You have a Master of Science, or similar, and a proven track record of global regulatory understanding and experience preferably within life cycle management. 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 and with the patient in mind, and you have a strong quality mind-set. You are a strong team player, but you also enjoy working independently. You have a positive attitude, good sense of humour, and you thrive in busy and changing circumstances, keeping your spirits high also under pressure. 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 Louise Buchholt Johansen at +45 3079 1381. Deadline 8 February 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