Global Labeling Delivery Manager
AstraZeneca / Apotekarjobb / Göteborg
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hela Sverige At AstraZeneca, we're not afraid to do things differently. We're building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening up new ways to work, pioneering cutting edge methods and bringing unexpected teams together.
The Global Labeling Group (GLG) at AstraZeneca is part of the Global Regulatory Affairs organisation and focuses on both the preparation and maintenance of labeling documents for prescribing information, patient information and regulatory information on packages for Health Authority approval. We are currently working on products for the EU and US markets.
We are now looking to hire a Labeling Delivery Packaging/Artworks Manager, on a permanent basis.
The packaging /Artworks Manager is responsible for the regulatory role towards creation of the printed material for products under development, updating of existing artworks for already marketed products, liaising with Marketing Companies in Europe as well as packaging sites within production.
The role
* Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
* Point of contact for the management of all labelling/artwork requests that require market/regulatory approval in US and EU centralised procedure, such as the creation, approval, and implementation of commercial printed labeling in collaboration with various functions
* Coordinates and/or leads the development and lifetime maintenance of packaging component labeling for commercial products, including introduction of new packs and new product launches, updates to existing packs, and mock-ups for regulatory submissions
* Provide tactical and strategic guidance to product labeling teams regarding regulatory requirements for packaging component labelling
* Understand industry labeling trends related to packaging and labeling content and implementation, reviewing competitor and other labeling
* Interpret US and EU labeling regulations and guidance, determining company impact and providing comments as appropriate
Essential Requirements for the role
* University Degree in Science or related discipline
* Relevant pharmaceutical experience, including regulatory experience, preferably working with labeling
* Knowledge of labeling regulations and guidance
* Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures.
Desirable Requirements
* Experience in packaging labeling development and/or maintenance
If you are interested, apply now!
Welcome with your application no later than October 21st , 2018.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2018-09-28ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2018-10-17
Ange följande referens när du ansöker: R-036554
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
jessica.tangefjord@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparredsleden 1
Jobbnummer 4373607
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