Regulatory Dossier Manager

Job Title: Regulatory Dossier Manager

Introduction to role:
Are you ready to make a difference in the world of regulatory affairs? As a Regulatory Dossier Manager, you'll play a pivotal role within the Regulatory Technology & Operational Excellence framework, supporting our global regulatory partners. Your mission is to assist in planning and coordinating major submissions worldwide, facilitating collaboration with publisher vendors, and navigating the operational landscape to ensure seamless submission projects to regional partners and Health Authorities. 

Accountabilities:
- Assist regulatory project teams to ensure efficient delivery of submission outputs and compliance with submission deliverables.
- Provide assistance to Submission Delivery Teams or regional Regulatory Affairs Managers (RAM), across therapeutic areas.
- Aid in defining and agreeing on cross-functional delivery plans and lead times.
- Support coordination of cross-functional deliverables and RTE publishing resources, including outsourcing partnerships.
- Gain understanding of partner Service Level Agreements (SLA) and service offerings.
- Monitor the execution of RTE delivery, addressing issues under guidance.
- Develop a thorough understanding of submission delivery across global markets, contributing to strategic planning and operational efficiency.
- Actively seek to understand and stay informed about regulatory requirements and updates from Health Authorities around the world. Incorporate this knowledge into submission strategies and practices.
- Foster strong relationships with internal teams, external customers, and partners.
- Contribute to the development of the Global Content Plan (GCP) for Market Applications and Line Extensions.
- Support Clinical and Safety contributions to the GCP/SCP.
- Support the Regulatory Dossier Lead (RDL) with complex submission activities.

Essential Skills/Experience:
- Bachelor’s degree (BA/BS) in Regulatory Affairs or a related scientific/technical field.
- At least 2-3 years of experience in the pharmaceutical/medical industry.
- Strong analytical and critical thinking skills, with excellent communication abilities.
- In-depth and extensive knowledge of the pharmaceutical drug development process.
- Exposure to global cross-functional project teams.
- Experience in one or more areas of Regulatory Affairs in the pharmaceutical or related industry.
- Familiarity with regulatory document or submission publishing, including various formats and market requirements.

Desirable Skills/Experience:
- Experience in supporting submission publishing activities.
- Understanding of Regulatory Life Cycle Management.
- Good knowledge of eCTD Publishing.
- Good knowledge with Veeva systems.

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 vision to eliminate cancer as a cause of death. Our team is dedicated to pioneering new frontiers in oncology research, fusing cutting-edge science with the latest technology to achieve breakthroughs. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we are committed to delivering impactful results. Empowered at every level, our collaborative research community works seamlessly with academia and industry partners to expedite research in some of the hardest-to-treat cancers. Join us and be part of a team that makes bold decisions driven by patient outcomes.

Ready to take on this exciting challenge? Apply now and become part of our journey!

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.