stillingsbetegnelse:
Senior Regulatory Professional – non-clinical development

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg Would you like to be part of Novo Nordisk Regulatory Affairs and part of “can-do” department located in Søborg, Denmark? If yes, then you may be our next Senior Regulatory Professional for RA Saxenda® and obesity projects. About this department Regulatory Affairs delivers a critical part of the drug development process. We are setting strategic direction towards approvals worldwide, ensuring competitive product labels and creating clear storylines across the huge amount of clinical documentation for the numerous submissions, often at the very centre of management and media attention. This means that we can promise you a fast-paced work environment where no two days are alike. Tight deadlines, cross-departmental collaboration, project management and international communication will be part of your busy workday. You’ll be expected to make an impact and to provide solutions and come up with new ideas if that’s what it takes. The job As Senior Regulatory Professional it is your responsibility to apply regulatory intelligence and develop regulatory strategies for our early projects within RA Saxenda® and obesity projects. You will be part of a regulatory affairs team working closely together and sharing responsibilities of providing the best regulatory input to activities related to development of new medicines. You will work closely with many important stakeholders and it will be your responsibility to prepare and maintain regulatory submission plans for all relevant regulatory activities. Furthermore, you will be reviewing non-clinical reports and assess the scientific non-clinical and clinical documentation intended for submission to regulatory authorities ensuring a high level of quality in everything that we do. Qualifications You hold a master’s degree in natural sciences and preferably also a PhD. You have a strong scientific insight into non-clinical development, regulatory affairs or the like gained from several years of work in the pharmaceutical industry, health authorities or similar. As a person, you thrive in busy environments and bring a can-do spirit and a healthy sense of humour to your work, even when the pressure is on. You are a strong team player contributing to the team both scientifically and socially. You also enjoy working independently on your own projects and always find solutions to the challenges you meet. In addition, you manage to focus on the detail while you focus on the long-term strategy. You are also a skilled communicator who is comfortable speaking and writing in English. It is your skills, your commitment, and your ambitions which help us to improve many people's lives. In return we offer you the opportunity to work with exceptionally talented colleagues, and we offer you a wide range of opportunities for professional and personal development. Contact For further information, please contact Christina Balslev Rindshøj on +45 3075 9092. 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