Nordic Regulatory Affairs Officer
Kelly Services AB / Kemiingenjörsjobb / Malmö
2011-08-24
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hela Sverige Sandoz is a global generics leader and a part of the Novartis Corporation. They save and improve lives by developing, producing and distributing high-quality, affordable pharmaceuticals. Thanks to their global network, Sandoz medicines are now available to 90% of people worldwide. In addition to direct cost savings to patients, Sandoz contribute to the stability of healthcare systems worldwide and free up resources for new and innovative medicines. Sandoz in the Nordic employs 80 people and their Nordic Head Office is located in Copenhagen in Orestad.
As part of a great team of 13 people, and in close collaboration with the global regulatory competence centers, you will take part in new submissions, renewals and variations for Sandoz products via CP, DCP and MRP in the Nordics.
Responsibilities
Your primary responsibilities include, but are not limited to:
Regulatory input to the Nordic organization
Handling of new submissions / renewals / variations, including preparation and submission of national texts
Keeping launch and labeling managers updated on timelines for new submissions and ongoing procedures
Close collaboration with QA and marketing in relation to launches
Text management in accordance with current guidelines of SmPC, PIL and labeling including preparation, proof reading and release for print
Coordinate Common Nordic Packaging materials
Negotiation with regulatory authorities
Keeping updated on EU and national legislation in each of the Nordic countries
Qualifications
The successful candidate is very professional and has the ability to work independently in a fast-paced environment. The following qualifications are required:
A Masters degree in Life Sciences
Experience from working in Regulatory Affairs and maintaining contact with relevant authorities, especially with the Swedish authorities
Excellent skills in English and Swedish - both verbal and in writing
You have strong analytical skills and you always look for possibilities instead of limitations
You work efficiently and are focused, and remain calm and in control even when you are busy
You have strong communication skills and work well with people on all organizational levels
You show responsibility and demonstrate accountability
We offer
A challenging job in an international organization, with a high degree of speed and independence.
You will work both as a generalist and as an expert with a high degree of professional competency and responsibility. You will get lots of opportunities to grow your professional and personal skills, based through a variety of independent and team based tasks.
Job application
Kelly Scientific is responsible for this recruitment to Sandoz. If you are interested in the above mentioned position, please visit our website:
www.kellyservices.se and search for Nordic Regulatory Affairs Officer in the nyckelord box, here you can upload your CV and application in a word document.
In case of questions related to this position, please contact Senior Scientific Consultant, Rebekka Christensen phone +45 3311 7070, or by mail:
We are looking forward to receive your CV and application.
Ansökan sker endast via nedanstående länk!
Publiceringsdatum2011-08-24Arbetstider och omfattningHeltidsanställd
ErsättningEnligt Överenskommelse
Så ansöker duAnge följande referens när du ansöker: SE306131
Ansökan kan tyvärr inte göras via e-post.
Ansökan sker via företagets webbplats.
KontaktFöretagKelly Services AB
AdressKelly Services AB
Regeringsgatan 77
11139 Stockholm
Jobbnummer 1011430
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