Global Labeling Delivery Manager

Global Labelling Delivery Manager – Packaging & Artworks, 1 year contract

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!

About the position
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, as well as creating and updating packaging components for our medicines. We are covering products for the EU and US markets.

We are now looking for a passionate colleague to join our team on a 12 month contract as a Global Labeling Delivery Manager. The role can be based at AstraZeneca’s dynamic R&D site in Gothenburg.
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.

Responsibilities
What you’ll do
• Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
• Ensure proper version control and document integrity of packaging component labeling, printed labeling artworks and other assigned labeling documents via proofreading.
• Assist in responding to labeling-related queries from various functional areas
• Assist Global Labeling team in resolution of labeling issues as needed
• Coordinates the development and lifetime maintenance of packaging component labeling for commercial products.
• 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


Your profile
Essential 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 for the role
Experience in packaging labeling development and/or maintenance.

About the organisation
This position is a consultant assignment for one year at AstraZeneca via QRIOS Life Science & Engineering in Göteborg. During this time you will be employed by QRIOS Life Science & Engineering.

QRIOS employs curious experts in IT, Life Science and Engineering. We want to continue to attract the best employees, to continue to support our partners with the important competences you require. We are a recruitment and consulting company that is strongly inspired by those who never stop looking for new solutions. As we say, QRIOS MINDS GO FURTHER.