.At AstraZeneca, we're not just about treating diseases - we're about defeating them. We're on a mission to turn innovative science into life-changing medicines, and we need your help. As a Reg Affairs Manager in our Oncology R&D department, you'll play a crucial role in gaining approval for our novel work on unmet medical needs. If you're ready to make a real difference in the world of healthcare, we want to hear from you.What you will do : The role holders effectively manage the delivery, compilation and production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges to deliver the needs for the international region and filings according to accelerated wave plans. They project manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product Lifecyle. The role holder will contribute and lead the regulatory CMC components of business-related projects. They will have effective levels of interactive communication with stakeholders and project team members to ensure relevant timelines and regulatory commitments are communicated.They will ensure the application of international CMC regulations and mentorship within AstraZeneca and lead/give to the development of new mentorship, policy, and processes.Lead the timely preparation (may include authoring) and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the lifecycle; including marketing authorisation applications and all post approval approval activities Accountable for delivering "submission ready" international CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures and ensuring submission quality.Documenting maintenance and communication of Health Authority approval status.Develops and builds expertise in regional regulatory requirements to ensure assurance of compliance of CMC submissions.Project management expertise with the ability to adapt to changing situations to ensure on time delivery.Ensure the learning from own projects are shared with other colleagues/within the functions.Supporting the agreed strategy to employ fit for purpose content applying regulatory intelligence and to optimise proposed submission contentParticipation in regulatory execution and delivery meetings and communicate and provide relevant updates to the international CMC team.Supply to business process optimisation activities to reduce waste and ensure efficiency.Continually evolve and develop the regulatory expertise through proactive recording and communications of Health Authority interactions, responses and commitments.Apply GxP principles according to the stage of product lifecycle
