Assignment within CMC Compliance Management

Proffice Life Science AB / Apotekarjobb / Södertälje
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On behalf of our client within pharmaceutical industry we are now looking for a candidate with experience in Regulatory Affairs for a one year consultant assignment. During this assignment you will have a position within Chemistry, Manufacturing and Controls (CMC) Compliance Management. You will work in teams that define and manage regulatory aspects of projects and produce CMC documentation for submission to Health Authorities worldwide.
The role
You will produce CMC documentation, presented in the required format to the agreed timetable, for worldwide registration of commercial products. You will use business wide electronic systems to maintain regulatory status up to approval of CMC documentation supplied by Global Regulatory Affairs within the company.
Depending on experience you may also provide operational and tactical regulatory CMC knowledge and direction to product and project teams in support of drug products at various stages of the product life cycle. You will be expected to use your regulatory knowledge to deliver to high standards, influence others and ensure the application of global CMC regulations and guidance within the company. The role offer opportunities to work with global networks.
Requirements
• An academic degree in Chemistry, Pharmacy or a related subject
• Excellent written and verbal English
Skills and Capabilities
• Ability to learn and keep up to date with new and changing regulations
• Team working skills
• Project management skills
• IT Software skills
• Concern for standards and accuracy
• Good communication skills
• Planning and organisation
• Ability to establish fruitful relationships and maintain networks
If you have the right background and qualification we encourage you to send your application immediately since interviews and candidate selection are done regularly! Special emphasis will be placed on personal suitability.
Last date of application: 2.11.2011.

Publiceringsdatum
2011-10-12

Arbetstider och omfattning
Visstidsanställning 6 månader eller längre
Heltid

Ersättning
Fast lön + rörlig lön

Så ansöker du
Ansökan kan tyvärr inte göras via e-post.

Kontakt
Linda Nord, Konsultchef, 0733434654, linda.nord@proffice.se

Företag
PROFFICE LIFE SCIENCE AB

Adress
PROFFICE LIFE SCIENCE AB
BOX 70368
10724 STOCKHOLM

Kontorsadress
MÄSTER SAMUELSGATAN 60
STOCKHOLM

Kontaktuppgifter
Telefonnummer: 08-7871700

Jobbnummer
1052929

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