Global Labelling Delivery Manager - Packaging & Artworks

Global Labelling Group

Hays Life Sciences is now looking to recruit a Global Labelling Delivery Manager - Packaging & Artworks to join the Global Labelling Group for a 1-year contract assignment at AstraZeneca in Gothenburg.

Do you have regulatory experience and knowledge within labelling 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 Labelling Group!

The Global Labelling Group (GLG) at AstraZeneca is part of the Global Regulatory Affairs organisation and focuses on both the preparation and maintenance of labelling 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 Labelling Delivery Manager. The role can be based at AstraZeneca's dynamic R&D site in Gothenburg.

The Global Labelling 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

* Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
* Ensure proper version control and document integrity of packaging component labelling, printed labelling artworks and other assigned labelling documents via proofreading.
* Assist in responding to labelling-related queries from various functional areas
* Assist Global Labelling team in resolution of labelling issues as needed
* Coordinates the development and lifetime maintenance of packaging component labelling for commercial products.
* 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 labelling in collaboration with various functions

Essential for the role

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

Desirable for the role

* Experience in packaging labelling development and/or maintenance.