Dossier Manager- Global Regulatory Operations

Dossier Manager - Global Regulatory Operations
Do you have expertise in, and passion for Global Regulatory Excellence? Would you like to apply your expertise to make an impact in a company that follows the science and turns ideas into life changing medicines? Then this unique role with a broad spectrum of responsibilities at AstraZeneca, might be the one for you!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.

We are now recruiting a Dossier Manager to our Dossier Management team within Global Regulatory Operations to our site in Gothenburg 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.

Global Regulatory Operations (GRO) manages several parts of Regulatory Information Management (RIM) within AstraZeneca. GRO has the expertise and provide the tools and services to be able to meet the ever increasing complexity of regulations and product portfolios, growing demand for data due to increased public and regulatory scrutiny, global collaboration and standardization of formats and processes across the markets and increased use of partners and outsourcing.

What you'll do
As a Dossier Manager you are acting as the first point of contact to the expertise within GRO regards to Document publishing, Submission Publishing and Submission Tracking. You provide a Global Regulatory Operation (GRO) interface to Regulatory partners and your responsibility is to support and navigate submission projects to regional partners and Health Authorities and update Lifecycle Management system for defined products.

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Collaborate and serve as a navigator for the Regulatory Project Teams, regards to the operational aspects of Publishing, Submission and Tracking of Regulatory submissions
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Develop and maintain strong partnerships with local and global customers and partners
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Update Lifecycle Management system for defined products
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Support Lifecycle Management reports to support lifecycle compliance

Essential for the role

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University Degree in Science or related experience
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Proven leadership skills of global cross functional project teams
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Relevant experience of working in one or more areas in Regulatory Affairs in the pharmaceutical or related industry
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Fluent in English, written and spoken

Desirable for the role

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Experience of working with Regulatory document or submission publishing, understanding the different procedures, formats and market requirements
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Planning for and managing submission publishing activities

Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together.

Interested? Come and join our journey.

So, what's next!
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.
We welcome your application no later than October 11th, 2020.

Where can I find out more?
Our Social Media,

Follow AstraZeneca on LinkedIn
https://www.linkedin.com/company/1603/

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Our Gothenburg site:
https://www.astrazeneca.com/our-science/gothenburg.html