International CMC Regulatory Affairs Manager I

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About the role

Job Title: International CMC Regulatory Affairs Manager I Global Career Level: D Role Type: Individual Contributor for International Markets About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines targeting some of the planet’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we 're dedicated to being a Great Place to Work. About the role Introduction to role The role holders effectively manage the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges (synthetics/biologics) to deliver the needs of both the AZ business and the customer. They project manage international 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 guidance within AstraZeneca and lead/contribute to development of new guidance, policy, and processes. Accountabilities Manage the timely preparation (include authoring) and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout marketing authorisation applications and all post approval activities Accountable for delivering “submission ready” 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 content Participation in regulatory execution and delivery meetings and communicate and provide relevant updates to the CMC team. Contribute 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 Responsibility for change management as assigned. Understands application of appropriate risk management across own activities. Demonstrate research skills in understanding regulations, and guidance from different regulatory agencies Essential Skills/Experience • University degree in a science or technical field such as pharmacy, biology, chemistry or biological science. • Minimum 8 years of Relevant experience from biopharmaceutical industry, or other relevant experience • Breadth of knowledge of manufacturing, project, technical and regulatory management. • IT Skills • Stakeholder & Project management • Professional capabilities: Regulatory knowledge Desirable Skills/Experience • Knowledge of the drug development process and regulatory submissions • Understanding of current regulatory CMC requirements • Direct/indirect Regulatory Affairs CMC experience with submissions for medicinal products • Understanding of regulations

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