Job Description

Job Title: Manager, Regulatory Information Management Systems

Career Level - D

Introduction to Role:


Join us at AstraZeneca as a Manager for Regulatory Information Management Systems. You will be a part of our Oncology R&D team, playing a key role in supporting the Regulatory Information Management (RIM) suite of tools. Our Enterprise Regulatory Vault (ERV) is a data-centric cloud/SaaS platform that enables compliance with current regulatory requirements and evolves to meet future needs. This role requires specialized knowledge to ensure that our customers gain full value from available information assets. Be empowered to make bold decisions, own them, and move at pace in an environment driven by speed.

Accountabilities:
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You will be providing expert system-related guidance and business support to users through personal interaction and online ticket management systems. You will work with product owners, business teams, and process owners to develop and support business processes pertaining to our RIM platform. Other responsibilities include business administration of systems, development of training and user support materials, writing scripts, and participating in system testing in support of system releases. You will also facilitate as the link between business and IS support.

Essential Skills/Experience:
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• Bachelor's degree or a proven track record of equivalent experience within a commercial environment.
• Experience of business administration for a validated application within a regulated environment, preferably within the pharmaceutical industry.
• Experience of delivering business support and/or training to end users.
• Fluent in written and verbal English.
• Knowledgeable in the drug development process, including regulatory documentation, submission, publishing, and approval processes.
• Experience of working with an enterprise-wide Document Management System and/or other Regulatory tools supported by GRO (e.g., publishing software, tracking databases).
• Ability to build relationships across cultures, functions, and disciplines to deliver a quality service.
• Excellent interpersonal skills.
• Delivery and customer-focused.
• Good organizational skills.


When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.


At AstraZeneca, we follow the science and pioneer new frontiers. Our Oncology team is dedicated to eliminating cancer as a cause of death. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. We are pioneers of collaborative research and have built an unrivalled scientific community both internally and externally. Join us and have the opportunity to build a rewarding and meaningful career as part of the team committed to improving the lives of millions with cancer.


Ready to make a difference? Apply today!