Regulatory Operations Manager

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 turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity. 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 now offer an exciting role as Regulatory Operations Manager within Global Regulatory Operations to our site in Gothenburg. You will have the opportunity to work together with a highly skilled and empowered global team to enable, facilitate and develop then entire regulatory publishing arena in AstraZeneca.

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
Global Regulatory Operations (GRO) has the people and knowledge to deliver accurate and timely regulatory dossiers to global health authorities. We have the platform and data to enable license to operate in hundreds of countries across the globe, and the technology and processes to maintain a robust, progressive Regulatory Information Management system to support our AstraZeneca business colleagues.

What you'll do
As Regulatory Operations Manager you will work collaboratively in a diverse and highly skilled global team. You will use your knowledge to effectively identify and analyse issues, research the situation, define problems, diagnose root causes and identify and evaluate solutions. A big part is to evaluate business needs and develop solutions using existing technology or driving adoption of new technologies as well as analyze and implement new Health Authority requirements regarding technical and formatting aspects of regulatory dossiers. You will function as the bridge between the business challenges, end to end business processes and the technology solutions, collaborating with internal clients and use in depth knowledge of your specialist area to work with them to achieve joint objectives.

Essential for the role

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Ability to apply project management principles and techniques, including scope, plan, define, and manage projects
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A broad working knowledge of process improvement methodologies, tools and techniques
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Ability to work independently and to set and manage priorities, resources, performance targets and project initiatives in a global environment
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Excellent English written and verbal communication skills

Desirable experience for the role

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Planning, preparation and delivery of regulatory submissions throughout the product's life cycle
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Working with digitalization and automation projects and initiatives
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Delivered innovative ways of exploiting and sharing data and utilise information management and data exploitation tools and techniques
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Robotic Process Automation, including development as well as governance in the RPA arena
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Pharmaceutical industry or knowledge of the drug development process and the product life-cycle
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System administration for validated applications within a regulated environment

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 30 November, 2020.
For more information regarding the position please contact Hiring Manager Ulf Klingnäs, +46 (0) 31 706 52 34.

Where can I find out more?
Our Gothenburg site: https://www.astrazeneca.com/our-science/gothenburg.html
Life in Gothenburg: https://www.movetogothenburg.com/
Culture and atmosphere of the Gothenburg site: https://www.linkedin.com/feed/update/urn:li:activity:6496327311678410752/