Global Labeling Delivery Manager

Do you have regulatory experience and knowledge within labeling combined with excellent communicating and negotiating skills? Would you like to apply your expertise in a global company where we work together across boundaries to make the impossible a reality? Then come and join us in the Global Labeling Group!

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 covering products for the EU and US markets.

We are now looking for a passionate colleague to join our team as a Global Labeling Delivery Manager for a permanent position. The role can be based at AstraZeneca's dynamic R&D site in Gothenburg and Södertälje, Sweden or Macclesfield, UK.

The Global Labeling Delivery 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.



What you'll do

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Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
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Point of contact for the management of all labeling/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
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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.
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Provide tactical and strategic guidance to product labeling teams regarding regulatory requirements for packaging component labeling
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Understand industry labeling trends related to packaging and labeling content and implementation, reviewing competitor and other labeling
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Interpret US and EU labeling regulations and guidance, determining company impact and providing comments as appropriate



Essential for the role

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University Degree in Science or related discipline
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Relevant pharmaceutical experience, including regulatory experience, preferably working with labeling
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Knowledge of labeling regulations and guidance
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Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures



Desirable for the role

Experience in packaging labeling development and/or maintenance.



So, what's next!

If you're curious to know more, please contact Hannah Mellström at Hannah.Mellstrom@astrazeneca.com

We welcome your application (CV and Cover Letter), no later than August 15, 2021.





Opportunity: Global Labeling Delivery Manager

Locations: Gothenburg, Södertälje (Sweden), Macclesfield (UK)

Salary: Competitive, with excellent benefits