Manager Regulatory Processes

Do you want to combine your regulatory process knowledge with your can-do attitude having the opportunity to work with experts across several groups?

We are now recruiting a Manager Regulatory Processes to join our Regulatory Process and Compliance team.

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.

In the Regulatory Process and Compliance team we network collaboratively to enable our customer groups to operate efficient processes in a compliant manner.

What you'll do
As a Manager Regulatory Processes you will be working with the Processes leads and Process Principals, supporting task related to management of AstraZeneca, processes including implementation, communication, compliance, performance and inspection readiness. You will be accountable to develop relationships across Regulatory Affairs and other relevant areas of AZ to execute the delivery of the assigned tasks in relation to processes strategy, priorities, alongside governance and management of the current procedural documents. This include to build relationships with stakeholders and customers to support pharmacovigilance and regulatory activities and responsibilities including successful partnerships. Working collaboratively to provide expertise and sharing best practices across all regions and in all partnerships to promote a culture of continuous improvement, high performance, flexibility and quality emphasising a "can do" attitude and innovative approaches. Additional accountabilities:

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Working with the Process leads and Principals, and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting
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Author and collaborate with SMEs to deliver assigned Toolkit documents and templates.
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Maintain and continuously improve key customer facing service solutions for Process guidance and document access (Submission Excellence SPOL, Lollipop, Q&A ticket portal etc).
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Coordinate specific tasks related to procedural document management to provide oversight to the regulatory process team
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Using understanding of PV and Regulatory processes and regulations to provide support to regulatory process team
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Identify opportunities to improve and simplify the methodology in processes and guidance, provide practical solutions and drive to implementation
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Support and improve reporting tools and analysis processes and process metric /KPI data. Performing the monitoring, analysis and trending of data in own area of work.
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Identify issues and risks in own area of work and propose options to mitigate them.
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Ensure that appropriate, up-to-date records are maintained for compliance
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support activities for GVP, GCP, GRP and GMP audits/inspections
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Support Delivery of improvement project assignments supporting the business,
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Provide process training to relevant functional groups or support preparation of training material.
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Seek personal and professional development opportunities, and share knowledge gained in open forums
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Contribute to communication and change management activities associated with process initiatives.

Essential for the role

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A science/pharmacy/nursing degree
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Experience in working cross-functionally
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Administrative skills including Sharepoint online expertise
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Project Management skills
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Good attention to detail
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Excellent written and verbal communication skills
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Proven ability to work across cultures

Desirable for the role

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Knowledge of Regulatory operating model and organisation
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Experience of working in a global organisation, preferably within the pharmaceuticals industry, and of the drug development life cycle and commercial aspects of the industry
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Experience of working with Procedural documents such as Standard Operating Procedures and Work Instructions

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?

Join us and be part of an outstanding place to work; an environment that energizes and empowers each of us to achieve our personal and organisational goals!

So, what's next?
Are you already imagining yourself in this position? Good, because we can't wait to hear from you!
Welcome with your application; CV and cover letter, no later than 14th of April, 2023.