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 end-to-end Regulatory Information Management, including dossier format, publishing, and tracking. Join us in our mission to bring life-changing treatments to patients around the globe
Responsibilities :
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 end-to-end 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.
Requirements :
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).
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 rapid-paced environment.