Job Title: Manager RIM (Regulatory Information Management)
Introduction to Role: At AstraZeneca, we put patients first and work to meet unmet needs worldwide. Working here means thinking big, being entrepreneurial, collaborating effectively, and exploring what science can achieve. If you are action-oriented, confident in leadership, open to collaboration, and driven by curiosity, you are the kind of person we seek. The Manager, Regulatory Information is responsible for supporting the management, collection, creation, and analysis of regulatory data and information. This role requires expertise in end-to-end Regulatory Information Management, including dossier formatting, publishing, and tracking.
Accountabilities:
Represent and manage the interface between Global Regulatory Operations (GRO) delivery units and both early- and late-stage drug projects.
Collaborate with GRO teams and partners to ensure efficient end-to-end Regulatory Information Management delivery.
Manage and govern regulatory data for assigned areas in compliance with regulatory data standards, business processes, and regulatory requirements.
Compile and deliver XEVMPD, IDMP, or other regulatory data submissions to health authorities.
Develop technical skills and regulatory knowledge critical to successful RIM delivery.
Engage with partners, affiliates, and stakeholders to manage regulatory data and ensure compliance with procedures and standards.
Monitor the environment for changes in legislation related to regulatory information.
Review and evaluate regulations, guidelines, and technical specifications impacting regulatory information processes and data standards.
Serve as a subject matter expert in the management, analysis, and quality control of regulatory data standards and information.
Essential Skills/Experience:
University degree in Life Sciences or equivalent experience in the pharmaceutical/medical industry.
Knowledge of the pharmaceutical drug development process.
Strong analytical and critical thinking skills.
Solid understanding of current regulatory legislation, guidelines, and trends relating to regulatory information processes, tools, and standards.
Desirable Skills/Experience:
Strong problem-solving and conflict resolution abilities.
Ability to set and manage priorities, performance targets, and project initiatives.
Expertise in innovating best practices through business process analysis and design.
Ability to excel in a fast-paced environment.
Work Environment: In-person working fosters the platform to connect, accelerate delivery, and challenge traditional thinking. AstraZeneca expects an average of three days per week from the office while providing flexibility to respect individual needs.
About AstraZeneca: At AstraZeneca, we inspire and support professional and personal growth through a clear career ladder, a recognition-driven culture, and exciting development opportunities for high achievers. We integrate data, technology, and scientific innovation to deliver life-changing medicines within an inclusive environment that values collaboration across academia, biotech, and industry.
Diversity and Inclusion: AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive team that represents diverse backgrounds and perspectives. Applications are welcomed from all qualified candidates regardless of their characteristics. AstraZeneca complies fully with applicable non-discrimination, employment authorization, and eligibility regulations.
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