stillingsbetegnelse: Regulatory CMC Expert within Biopharmaceuticals

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 challenging and a truly interesting place to work - are you up for the challenge? About the Department RA CMC Biopharm in Regulatory Affairs is a dedicated department of 13 people. You will work with experienced and engaged colleagues working closely with development, production and quality departments. We are supporting a diverse portfolio of Biopharm products within development and marketed products. In this dynamic environment, our dedicated group prepares the regulatory strategies and is responsible for global interactions with regulatory authorities. We have a strong team-spirit and together we go the extra mile to succeed. The Job The position is located in Søborg in the Copenhagen area. As RA CMC Expert you will be expected to challenge and secure the CMC input to global regulatory strategies and submissions for development and LCM projects. You will use your remarkable insight of RA intelligence to enhance the quality of the strategies and enhance the quality of the regulatory submissions. You will work closely with the various product teams supporting the product portfolio and the regulatory project managers, who are overall responsible for the regulatory part of our projects. In addition, you will chair an expert group for sharing of intelligence and knowledge. You will report directly to the manager of the department. Qualifications You have a proven track record of minimum 5 years of employment from a global Biopharmaceutical company or from a Medical Health Authority working with RA CMC disciplines. You need to have a biology/health science university degree. You have a natural interest in RA intelligence, and you are frequently following up with the latest legislation. Furthermore, your scientific understanding is at a very high level.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 your focus on jointly moving the projects but you can also work independently. You enjoy being challenged, and come up with new solutions. 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 Jacob Larsen +45 3079 1441. Deadline 15 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