stillingsbetegnelse:
Regulatory Professional in Regulatory Affairs (temporary position)

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg Join Regulatory Affairs and become part of a fast-changing environment where engaged people do their best every day to get Novo Nordisk medicines approved across the globe. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting place to work – but also quite challenging. We are currently looking for a Regulatory Professional (12 months temporary position, 1 August 2016 to 30 July 2017) with an interest in working with regulatory clinical submission activities to join our Insulin and GLP-1 Combination department. About the department In the Insulin and GLP-1 combination department we are 9 dedicated employees working with all the clinical regulatory activities for the Insulin and GLP-1 Combination Projects. The position You will be substituting for one of our Regulatory Professionals. You will drive the clinical submission activities for one of our products in close collaboration with internal stakeholders, affiliates and health authorities worldwide. Driving clinical Life Cycle Maintenance (LCM) activities by being responsible for regulatory evaluation of LCM ideas and authority requests, chairing cross-functional submission teams, planning, preparing, compiling and submitting documentation to authorities and ensuring regulatory approvals. You will work in a fast paced environment with tight deadlines where no two days are alike, and you will be supported by friendly colleagues with a good sense of humour. Qualifications We expect you to have a Master’s degree in science and some years of experience from working in Regulatory Affairs in the Pharma industry, preferably with clinical regulatory activities. You have profund planning and coordination skills and are a strong communicator who will make stakeholders deliver their best within the ever-changing environment and timelines. You have a flair for IT systems and experience with MS Office applications. 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 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. Working at Novo Nordisk 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 Marianne Bork Samuelsen at +45 3079 6941 or Birgitte Lysgaard-Jensen at +45 3079 2427. Deadline 12 June 2016.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark