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Labeling Artworks Associate Director

Location Gothenburg, Västra Götaland County, Sweden Job ID R-138353 Date posted 12/05/2022

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 organization 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 Labeling Artworks Associate Director at the Gothenburg site in Sweden. Our Gothenburg site is one of AstraZeneca's three strategic science centers. We thrive in a multinational environment working cross-functionally across the globe with AstraZeneca colleagues as well as academic and industry partners. Our way of life is to foster a working environment that nurtures, collaboration, openness and innovation. Therefore, we have created space for meetings, socializing and relaxation, where spontaneous meetings can give birth to new innovations. The unexpected ideas or thoughts that can come from a chat over something as simple as a cup of coffee or a stroll on our “walk and talk” meeting trail.

What you’ll do

As Associate Director you will be 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. You will provide tactical and strategic guidance to product labeling teams regarding regulatory requirements for packaging component labeling as well being the 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.

  • Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.

  • 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.

  • 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

With this in mind we are looking for you that have the ability to build relationships, having multi-cultural awareness and sensitivity; communicating and negotiating in diverse cultures with a good outcome. You like to think strategically, appropriately assess risks and formulate strategies to manage risk.

Essential for the role

  • University Degree in Science or related discipline

  • Pharmaceutical experience, preferably regulatory experience, preferably working with artwork management and labeling

  • Knowledge of labeling regulations and guidance

  • Negotiation Skills (good listener; able to build a consensus)

  • Critical Information Seeking (works well across formal and informal networks)

  • Rational Persuasion (able to distil an issue to its key components and suggest solutions)

  • Interpersonal Awareness (aware of how actions affect other people)

Desirable for the role

  • Experience in packaging labeling development and/or maintenance.

  • Regulatory experience

Why AstraZeneca?
Our purpose is ambitious and so is our approach. Becoming a more agile and innovative company means building a dynamic, inspiring culture where we celebrate forward thinking and act with a sense of urgency. We are ambitious, take informed risks and learn from both success and failure. We are curious, creative and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Are you ready to move forward in your career?

You will be offered a competitive salary and excellent benefits, such as extra paid Holiday, Private Medical Benefits, On-site exercise and much, much more.

So, what’s next!

We would like to know more about you. If you are interested, apply now!

Welcome with your application no later than 2 June, 2022

Find out more

The Gothenburg site:

Culture and atmosphere of the site:

Life in Gothenburg and Sweden:

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

50056704 E RGPD R&D Oncology (Susan Galbraith (07016555)) (85008610)

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.