Manager, Regulatory Information

Introduction to role

Are you passionate about regulatory information management and looking to make a significant impact in the pharmaceutical industry? 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, ensuring that our transformative science reaches those in need.

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 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.

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)

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 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 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 life-changing 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 and our business.

Ready to make a difference? Apply now to join our team!

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.