Jobs / Saudi Arabia / Astrazeneca Pharmaceuticals Lp
Regulatory Affairs Senior Specialist, Regional CoE
Astrazeneca Pharmaceuticals Lp · 🌍 Central-Riyadh
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About the role
Regulatory Affairs Senior Specialist – Regional Centre of Excellence ABOUT ASTRAZENECA 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. SITE DESCRIPTION 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. ROLE SUMMARY 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 manner and in compliance with the highest global regulatory standards. We are seeking a Senior Regulatory Affairs Specialist to join our Regional Regulatory Centre of Excellence (CoE), a specialized unit that serves as the operational delivery arm for Life Cycle Management (LCM) regulatory activities on behalf of Marketing Companies (MCs) across multiple markets. If you have solid regulatory affairs experience, a quality-focused mindset, and the ability to work effectively in agile, matrixed, and multicultural environments, this is your opportunity. The Senior Regulatory Affairs Specialist within the Regional CoE manages the operational delivery of LCM activities for assigned countries or clusters. The role works closely with MC teams, iRAMs, iRADs, and international iCMC teams, applying approved regulatory strategies and market-specific requirements to produce high-quality submission packages ready for filing with Health Authorities. The scope of the role covers dossier preparation and customization, coordination of responses to Health Authority queries, maintenance of regulatory systems, and implementation of post-approval changes. What you’ll do • LCM Planning and Delivery: Plan and execute assigned LCM activities in line with market plans, agreed priorities, internal objectives, local requirements, and applicable global procedures. • Dossier Preparation and Customization: Compile and customize submission dossiers, including country-specific Module 1 content, national forms, declarations, cover letters, administrative documents, and supporting records. • CMC and Non-CMC Content Coordination: Coordinate with international iRAMs, iRADs, and iCMC teams to identify content gaps and ensure timely availability of approved source documents and technical responses • Submission Execution: Execute or support the timely submission of dossiers according to the market operating model, including administrative steps and submission evidence where applicable. • Health Authority Query (HAQ) Management: Monitor review milestones, anticipate Health Authority questions, and coordinate complete, consistent, and timely responses with MC and international partners. • Approval Tracking and Implementation: Obtain and track LCM approvals or notifications and coordinate implementation of variations, renewals, commitments, and other post-approval changes, including PSURs/PBRE