Manager, Regulatory Information
Manager, Regulatory Information
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Job Description
Introduction to role
Are you ready to make a difference in the world of regulatory information management As the Manager Regulatory Information you will support the management collection creation and analysis of regulatory data and information. You will be an expert in endtoend Regulatory Information Management including dossier format publishing and tracking. Join us in our mission to bring lifechanging treatments to patients around the globe!
Accountabilities
Represents and manage the interface between RTE (Regulatory Technology and Operational Excellence) delivery units and early as well as late stage drug projects.
Collaborates with internal AstraZeneca teams and external partners such Clinical Research Organizations to assure efficient and accurate management of endtoend Regulatory Information Management.
Manage and govern the regulatory data for assigned areas of responsibilities in accordance with regulatory data standards business processes and regulatory requirements and ensuring compliant usage to ensure that the objectives of the regulatory information remit are met.
Develops self in topic areas critical to successful delivery of the RIM remit. Particularly technical skills and knowledge of international regulations.
Engages with partners affiliates or other customers and stakeholders to manage regulatory data and to ensure compliance with procedures and standards.
Monitors the environment for changes in legislation related to regulatory information. Reviews and evaluates regulations guidelines and technical specifications related to regulatory information processes and regulatory information data standards.
Subject matter expert in the management analysis and quality control of regulatory data standards and regulatory information.
Essential Skills/Experience
University degree in the life sciences or equivalent experience in the pharmaceutical/medical industry.
Knowledge of pharmaceutical drug development process.
Strong analytical and critical thinking ability.
Good understanding of current regulatory legislation guidelines and trends relating to regulatory information (process tools standards).
Desirable Skills/Experience
Good problem and conflict resolution skills.
Ability to set and manage priorities performance targets and project initiatives.
Ability to innovate best practices with business process analysis and design.
Ability to thrive in a rapidpaced environment.
When we put unexpected teams in the same room we unleash bold thinking with the power to inspire lifechanging medicines. Inperson working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 bring hope and solutions to patients with unmet needs across the globe. As part of our Oncology Regulatory team you will work on innovative approaches to bring lifechanging treatments to patients efficiently. Our inclusive and diverse environment empowers you to take smart risks and uncover new ways to deliver better outcomes for patients. Collaboration is key here; we share knowledge across locations and therapy areas to drive innovation and achieve our goals.
Ready to make a difference Apply now and join us in our mission to transform patients lives!
Date Posted
09abr2025Closing Date
30jun2025AstraZeneca 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 industryleading 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 nondiscrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.
Required Experience:
Manager
Employment Type
Full-Time
