International CMC Regulatory Affairs Manager I

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.

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.

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

AstraZeneca offers the chance to work on meaningful science that directly shapes how life-changing medicines reach patients worldwide, with a rich pipeline that spans the full drug development journey. Regulatory professionals collaborate across locations, therapy areas and external partners to solve complex problems, use data and analytics to shorten development cycles, and pioneer modern regulatory approaches for niche patient populations. It is an inclusive environment where diverse perspectives are valued, people are trusted with real responsibility, encouraged to ask questions, try new ideas and act as agents of change, while benefiting from global opportunities to grow skills, explore different roles and build a long-term career.

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Ready to step up, drive impactful CMC submissions and help bring transformative medicines to patients faster? Apply now. 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 align with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

25-Aug-2026

10-Sept-2026 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 authorization and employment eligibility verification requirements.