Job Description

Job Title: Manager, Regulatory DataIntroduction to role:Are you ready to make a significant impact in the world of regulatory data management? As a Manager, Regulatory Data at AstraZeneca, you will support data management, analysis, and quality control of regulatory data standards (XEVMPD, IDMP) and regulatory information. Join us in our mission to deliver life-changing medicines to patients around the world.Accountabilities:- Perform operational activities for assigned elements of the regulatory information management process, XEVMPD, and the Global Product Registration List in accordance with quality control and quality improvement methodologies.
- Act as a Data Steward for assigned regulatory data assets, maintaining and managing regulatory data as per the Enterprise Data Quality Framework.
- Support the administration of regulatory data standards (XEVMPD, IDMP) and the processes used to govern the collection, coding, analysis, and quality control of regulatory information.
- Compile and deliver XEVMPD or other regulatory information-based submissions to health authorities.
- Develop expertise in critical topic areas such as technical skills (XEVMPD, IDMP), knowledge of international regulations, and other skills (communication, project management).
- Support changes based on intelligence about the regulatory environment and changes related to regulatory information practices. Provide operational support for new or optimized business processes to match environmental changes.
- Support continuous improvement initiatives.
- Prepare business reports, analyses, or alerts in response to business needs or health authority requests.
- Ensure collection and coding of regulatory information is done in compliance with regulatory and pharmacovigilance legislation, regulatory processes, and regulatory data standards. Review results of audits to ensure accuracy and compliance with regulations and procedures.Essential Skills/Experience:- University degree in the life sciences
- Experience in pharmaceutical/medical industry
- Strong analytical and critical thinking ability
- Knowledge of pharmaceutical drug development process
- Good understanding of current regulatory legislation, guidelines, and trends relating to regulatory information management (process, tools, standards)Desirable Skills/Experience:- Manages change with a positive approach to the challenges of change for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business.
- Excellent written and verbal communication skills, negotiation, collaboration, and interpersonal skills.
- Good problem and conflict resolution skills.
- Demonstrated ability to set and manage priorities, resources, performance targets, and project initiatives in a global and regional environment.
- 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 are driven by a bold ambition to eliminate cancer as a cause of death. Our Oncology Business Unit is dedicated to following the science and challenging the status quo to deliver more effective treatments to patients in need. We foster a culture of inclusion and belonging where everyone can bring their true selves to work. With access to industry-leading research, technology, and a game-changing pipeline, you will have the opportunity to make a real difference in the fight against cancer.Ready to take on this exciting challenge? Apply now and be part of our journey to change lives!Date Posted 05-May-2025Closing Date 25-May-2025AstraZeneca 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 authorization and employment eligibility verification requirements.

AstraZeneca