Regulatory Affairs Senior Specialist Regional CoE

About AstraZeneca

AstraZeneca is a global biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines for serious diseases. The company operates with a science-led, patient-focused approach.

Role Overview

AstraZeneca is seeking a Regulatory Affairs Senior Specialist to join its Regional Regulatory Centre of Excellence (CoE) in Riyadh, Saudi Arabia. This full-time role involves managing the operational delivery of Life Cycle Management (LCM) regulatory activities for assigned countries or clusters. The specialist will work within a specialized unit that supports Marketing Companies (MCs) across multiple markets, ensuring timely and compliant delivery of medicines.

Key Responsibilities

• Plan and execute assigned LCM activities in alignment with market plans, priorities, internal objectives, local requirements, and global procedures.
• Compile and customize submission dossiers, including country-specific Module 1 content, national forms, declarations, cover letters, administrative documents, and supporting records.
• Coordinate with international iRAMs, iRADs, and iCMC teams to identify content gaps and ensure timely availability of approved source documents and technical responses.
• Execute or support the timely submission of dossiers according to the market operating model, including administrative steps and submission evidence.
• Monitor review milestones, anticipate Health Authority questions, and coordinate complete, consistent, and timely responses with MC and international partners.
• Obtain and track LCM approvals or notifications and coordinate implementation of variations, renewals, commitments, and other post-approval changes, including PSURs/PBRERs and safety data cutoffs.
• Manage label customization, artwork coordination, implementation workflows, compliance verification, and maintenance of labeling.
• Support product license maintenance, operational Marketing Authorization Holder (MAH)-related activities, and divestment or transfer activities for assigned products.
• Coordinate translations of Health Authority communications, approvals, and dossier components, with final validation provided by the responsible MC.
• Maintain accurate and timely records in RIM, ERV, and other required regulatory systems in accordance with established procedures, standards, and KPIs.
• Apply relevant LCM regulatory intelligence through approved channels, escalating changes that may impact strategy, content, timelines, supply, or compliance.
• Provide transparent status reporting, risk escalation, and decision records to MC teams, CoE leadership, iRAMs, iRADs, and iCMC teams.
• Contribute to the development of standard templates, playbooks, dashboards, automation initiatives, and lessons learned.

Qualifications and Experience

• 2-5 years of solid regulatory affairs experience.
• Demonstrated quality-focused mindset.
• Ability to work effectively in agile, matrixed, and multicultural environments.

Work Environment

This role is based in Riyadh, Riyadh, Saudi Arabia. AstraZeneca in Saudi Arabia is undergoing a transformation focused on advancing healthcare and innovation, aligning with Saudi Vision 2030. The environment calls for agile professionals motivated to contribute to the future of healthcare in KSA.

Company Commitment

AstraZeneca is committed to pioneering science to improve patient lives. The company fosters an inclusive culture that champions diversity and collaboration, supporting continuous learning, growth, and development.