Regulatory Affairs Senior Manager, Regional CoE

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

AstraZeneca is experiencing a significant transformation in the Kingdom of Saudi Arabia, driven by a commitment to advancing healthcare, innovation, and sustainable growth. Building on our global legacy, AZ KSA is rapidly evolving its operations to better serve patients, collaborate with healthcare stakeholders, and contribute to the ambitious goals outlined in the Saudi Vision 2030. We are investing in talent, digital solutions, and new ways of working;

all designed to enhance our impact on patient outcomes and reinforce our leadership in therapeutic areas. This dynamic environment calls for visionary, agile professionals who thrive in change and are motivated to help shape the future of healthcare in KSA.

At AstraZeneca, we are driven by a bold ambition: to continue pioneering science to improve the lives of millions of people. Our Regulatory Affairs team is an essential part of that mission, ensuring that our medicines reach patients in a timely, safe, and compliant manner while meeting the highest global regulatory standards.

AstraZeneca is seeking a Regulatory Affairs Senior Manager to join the Regional Regulatory Centre of Excellence (CoE) and lead the operational execution of Life Cycle Management (LCM) activities for assigned products across assigned markets.

The role requires a combination of senior regulatory expertise, technical and CMC judgment, matrix leadership, portfolio management, and the ability to drive scalable and efficient operating models. The position will contribute to reducing the operational burden on local teams while maintaining the Marketing Companies’ accountability for market decisions, health authority interactions, and local legal obligations.

• LCM Portfolio Leadership: Lead the regional Life Cycle Management portfolio, ensuring alignment with business priorities, agreed service levels, and quality and compliance expectations.
• Demand and Resource Management: Manage intake, prioritization, work allocation, capacity visibility, and governance of activities transferred from Marketing Company teams.
• Operational Strategy and Regulatory Execution: Lead complex or high-impact activities related to dossier customization, regulatory submissions, national requirements, post-approval pathways, and CMC change management.
• Dossier Preparation: Ensure the preparation, compilation, and quality review of country-ready regulatory packages, including Module 1, national forms, cover letters, declarations, local administrative documentation, translations, and ERV activities where applicable.
• Submissions and Tracking: Execute or support regulatory submissions under the agreed operating model, maintain submission evidence, and ensure regulatory records remain complete and current.
• Health Authority Questions Management: Coordinate the receipt, assignment, consolidation, and timely submission of responses to health authority questions, ensuring appropriate involvement of Marketing Companies, iRAMs, iRADs, and iCMC.
• Implementation and Closure: Oversee approval follow-up activities, implementation of variations and commitments, regulatory system updates, and compliant closure of activities.
• Labeling Adaptation and Implementation: Where applicable, lead regional capabilities for labeling adaptation and implementation, ensuring appropriate use of tools, templates, and quality controls.
• Standardization and Continuous Improvement: Design and enhance processes, templates, national requirements guides, artwork coordination workflows, and automation opportunities to improve efficiency and right-first-time quality.
• Risk Management: Identify and manage regulatory, CMC, supply, quality, resource, and timeline risks, recommending and implementing appropriate mitigation measures.
• Issue Resolution: Lead the investigation and resolution of portal rejections, administrative non-compliance, execution failures, or schedule deviations, including root cause analysis and implementation of corrective actions.
• Governance and Performance Management: Manage performance indicators related to workload volume, timeliness,…