Manager RIM (Regulatory Information Management)
Job Title: Manager RIM (Regulatory Information Management)
Introduction to role
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. The Manager, Regulatory Information is responsible for supporting the management, collection, creation and analysis of regulatory data and regulatory information. The Manager, Regulatory Information is an expert in end-to-end Regulatory Information Management (dossier format, publishing, tracking).
Accountabilities:
·Represents and manage the interface between Global Regulatory Operations (GRO) delivery units and early as well as late stage drug projects.
·Collaborates with GRO teams and partners to assure efficient delivery 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.
·Compiles and delivers XEVMPD, IDMP or other regulatory data submissions to health authorities.
·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 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)
Descried 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 rapid paced environment
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 inspire and support your professional and personal growth. With a defined career ladder, a recognition culture that celebrates successes, and exciting opportunities for those with the drive to achieve, we are committed to helping you progress and develop fast.
Ready to make a difference? Apply now!
AstraZeneca 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 industry-leading 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 non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
