Regulatory Dossier Manager

Job Description

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, youll 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. 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! 11-Jun-2025