Labeling Operations Manager/Associate Director
AstraZeneca Göteborg / Apotekarjobb / Mölndal
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hela Sverige Labeling Operations Manager/Associate Director, Delivery and Enablement (2 roles)
Approximately 200 professionals at AZ Gothenburg work on Global Regulatory Affairs, Patient Safety and Quality Assurance (GRAPSQA). The focus is on both small molecules and biologics.
This roles can be based in Sweden, Gothenburg or UK, Macclesfield or US, Gaithersburg.
The arena
The Global Labeling Operations Manager/Associate Director is responsible for the regulatory role as part of the process for coordination, development and implementation of new and revised printed labeling for assigned commercial products. Coordinate and/or lead packaging component labeling content development and support the labeling content development
The role
Point of contact for Regulatory Affairs towards the process for the creation, approval, and implementation of commercial printed labeling in collaboration with various functions
Coordinates and/or leads cross-functional teams in the development and lifetime maintenance of the US, EU and other regional packaging component labeling for all commercial products
Provide tactical and strategic guidance to product labeling teams regarding placement and regulatory requirements for regional packaging component labeling content and design
Manage labeling submissions for US and EU, including Quality Check, proofing, copy editing and formatting of documents, and coordinate review and approval of final submission
Understand industry labeling trends related to packaging and labeling implementation, reviewing competitor and other labeling
Interpret regional labeling regulations and guidance, determining company impact and providing comments as appropriate
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Tillsvidare
Heltid
Publiceringsdatum2016-02-10ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2016-02-24
Ange följande referens när du ansöker: GOT0000002Z
FöretagAstraZeneca Göteborg
AdressAstraZeneca Göteborg
43183 MÖLNDAL
KontorsadressPEPPAREDSLEDEN 1
MÖLNDAL
Övriga kontaktuppgifterTelefonnummer: 031-7761000
Jobbnummer 2664794
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