Regulatory Affairs Manager

Kelly Services AB / Försäljarjobb / Malmö
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We are always looking for talented candidates within Regulatory Affairs to join the team, in a International Pharmaceutical Company. We are looking for talented people in Sweden, from the area of Malmö/ Lund to work in Copenhagen
Responsibilities
Your primary responsibilities is:
• 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
• Negotiation with regulatory authorities
• Close collaboration with QA and marketing in relation to launches
• Text management in accordance with current guidelines
• Coordinate Common Nordic Packaging materials
• 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
• At least 2 years 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
If you are interested in the above mentioned position, please visit our website: http://www.kellyservices.se/www.kellyservices.se and search for Regulatory Affairs Manager, 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 by mail: :@kellyservices.dk
We are looking forward to receive your CV and application.
Ansökan sker endast via nedanstående länk!

Publiceringsdatum
2011-11-09

Arbetstider och omfattning
Heltidsanställd

Ersättning
Enligt Överenskommelse

Så ansöker du
Ange följande referens när du ansöker: SE316022
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Klicka på denna länk för att göra din ansökan

Kontakt
Företag
Kelly Services AB

Adress
Kelly Services AB
Regeringsgatan 77
11139 Stockholm

Jobbnummer
1075605

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