stillingsbetegnelse: Regulatory Proffesional

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg Join 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 the ability to navigate many agendas and stakeholders. This makes Regulatory Affairs a truly interesting place to work but also challenging. Are you up for the challenge? About the department RA CMC Biopharm part of RA CMC Biopharmaceutical in Regulatory Affairs is a dedicated department of 13 people. You will work with experienced and engaged colleagues working closely with production and quality departments. We are supporting all marketed products within growth hormone, Hormone replacement therapy, GlucaGen & OAD (Oral anti-diabetic). In this dynamic environment, our dedicated group prepares the regulatory strategies and is responsible for global interactions with regulatory authorities. We work closely with many different stakeholders within Novo Nordisk headquarters and affiliates. We have a strong team-spirit and together we go the extra mile to succeed. The job The position is located in Søborg and you will be part of various product teams with Regulatory Project Managers, Professionals and Associates. Your role will be to diligently secure the CMC input to global regulatory strategies and submissions for LCM projects and maintaining LCM daily support. You will plan, coordinate and review regulatory documentation and chair internal working groups as our primary sparring partner for the Production and CMC 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. In addition, you will be part of cross functional teams sharing your knowledge and getting new ideas. You will report to the manager. Qualifications As a minimum, we expect you to have a biology/health science university degree plus experience from pharmaceutical Industry working with regulatory aspects of CMC 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 are organised, detail-oriented and a proactive problem-solver. 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 circumstances and bring a can-do attitude and a healthy sense of humour. You keep focus on jointly moving the projects and are able to work independently, be challenged and find new solutions. At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. Contact For further information, please contact Jacob Larsen at +45 3079 1441. Deadline 20 May 2015.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse:
Arbejde inden for biologi, botanik, zoologi og beslægtede områder

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark