stillingsbetegnelse: Senior Regulatory Professional

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg We have an open position as senior regulatory professional within RA CMC Haemophilia and you have the possibility of joining 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 and ability to navigate many agendas and stakeholders at the same time. This makes Regulatory Affairs a truly interesting place to work but also challenging. Are you up for the challenge? About the Department The RA CMC Haemophilia department is part of RA CMC Biopharmaceutical in Regulatory Affairs and is situated in the Novo Nordisk project house together with other regulatory affairs functions in Søborg. We are a group of 15 highly skilled and dedicated people involved in every CMC aspect concerning the marketed products (NovoSeven®, NovoEight® and NovoThirteen®) as well as projects in development within Haemophilia. You will work with experienced and engaged colleagues and work closely with many different stakeholders within Novo Nordisk headquarters and affiliates. In this dynamic environment, our dedicated group prepares worldwide regulatory strategies for CMC submissions and is responsible for interactions with regulatory authorities. The Job As senior regulatory professional you will be part of various product teams with Regulatory Project Managers, Professionals and Associates. You will be involved in Life Cycle Management (LCM), general maintenance of marketing authorisations and/or development of new products within Haemophilia. Your role will be to diligently secure the CMC input to global regulatory strategies and submissions. You will plan, coordinate and review regulatory documentation, chair internal working groups and be our primary RA point of contact for the Production and Product Support units in Novo Nordisk. You will work closely with the Regulatory Project Manager, who is overall responsible for the regulatory part of our projects. Qualifications We expect you to have a Master of Science in Pharmacy or other similar university degree as well as post graduate training within regulatory affairs. Furthermore we expect you to have documented regulatory experience from pharmaceutical industry working with regulatory aspects of CMC for Biologics in development or Life Cycle Management projects. You have a solid scientific understanding and you have successfully worked in project teams respecting the contribution of everyone. You communicate well and are completely comfortable speaking and writing English and can deal with the challenges of international communication. On a personal level, you are a team player and thrive in busy and changing environment and bring a can-do attitude and a healthy sense of humour. You keep focus on meeting the project targets and timelines, work independently are challenging and find new solutions to reach the goals. At Novo Nordisk, your skills, commitment and ambition help us change lives for the better. In exchange, we offer you a chance to work with extraordinary talent and to develop professionally and personally. Contact For further information, please contact Tina Meinertz Andersen +45 3079 8717. Deadline 20 November 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