stillingsbetegnelse:
Senior Regulatory Professional in Insulin & GLP-1 projects

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg Join a fast-changing environment where engaged people do their best every day to get Novo Nordisk’s medicines approved 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? We are currently looking for a Senior Regulatory Professional with an interest in working with labelling as well as clinical development and Life Cycle Management (LCM) activities to join the Insulin and GLP-1 Combination Project team. About the department In the team, we are 8 regulatory associates and professionals working with all the clinical regulatory activities for the Insulin and GLP-1 Combination Projects. The job Your key responsibility will be developing and maintaining the CCDS, European SmPC and national labels for the combination projects in our portfolio. You will drive the labelling activities in close collaboration with internal stakeholders, affiliates and health authorities worldwide. Driving the labelling activities means being responsible for regulatory assessment of the impact of LCM initiatives and authority requests, evaluating trends in environment and competitor landscape, chairing cross-functional teams, submitting documentation to authorities and ensuring regulatory approvals. You will also be supporting the regulatory associate in handling labelling change requests and other requests from affiliates and other stakeholders. You will ensure that stakeholders across many different areas and nationalities function as a team, despite potentially conflicting interests. You will work in a fast paced environment with tight deadlines where no two days are alike, and you will be supported by a team of friendly colleagues with a good sense of humour. Qualifications We expect you to have a Master degree in science and minimum five years’ experience from working in Regulatory Affairs in the Pharma industry, preferably with clinical regulatory activities. 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 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 keep your spirits high also under pressure. At Novo Nordisk we strive for excellence. As a world leader in in diabetes care and a major player in haemostasis and hormone replacement therapy, we offer our employees opportunities for continuous growth. Contact For further information, please call Marianne Bork Samuelsen at +45 3079 6941. Deadline 16 September 2015.

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