Regulatory Affairs Senior Manager 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 is undergoing a significant transformation in the Kingdom of Saudi Arabia, driven by a commitment to advancing healthcare and innovation. This evolution aims to better serve patients, collaborate with healthcare stakeholders, and contribute to the Saudi Vision 2030.

About the Role

AstraZeneca is seeking a Regulatory Affairs Senior Manager to join the Regional Regulatory Centre of Excellence (CoE) in Riyadh, Saudi Arabia. This full-time role involves leading the operational execution of Life Cycle Management (LCM) activities for assigned products across designated markets. The position requires senior regulatory expertise, technical and CMC judgment, and matrix leadership to drive efficient operating models and reduce operational burdens on local teams while maintaining market accountability.

Key Responsibilities

• Lead the regional Life Cycle Management portfolio, ensuring alignment with business priorities, service levels, and compliance.
• Manage intake, prioritization, work allocation, capacity visibility, and governance of activities from Marketing Company teams.
• Lead complex activities related to dossier customization, regulatory submissions, national requirements, post-approval pathways, and CMC change management.
• Oversee the preparation, compilation, and quality review of country-ready regulatory packages, including Module 1, national forms, and administrative documentation.
• Execute or support regulatory submissions, maintain submission evidence, and ensure regulatory records are complete and current.
• Coordinate responses to health authority questions, ensuring timely submission and appropriate stakeholder involvement.
• Oversee approval follow-up activities, implementation of variations, regulatory system updates, and compliant activity closure.
• Lead regional capabilities for labeling adaptation and implementation, utilizing appropriate tools and quality controls.
• Design and enhance processes, templates, and workflows to improve efficiency and quality.
• Identify and manage regulatory, CMC, supply, quality, resource, and timeline risks, recommending mitigation measures.
• Lead the investigation and resolution of portal rejections, administrative non-compliance, and schedule deviations.
• Manage performance indicators related to workload volume, timeliness, quality, and response times.
• Provide matrix leadership, coaching, knowledge transfer, and specialized expertise within the team.
• Build strong relationships with Regulatory leaders and partners across various functions.
• Ensure activities comply with Good Regulatory Practice (GRP), AstraZeneca policies, GxP requirements, and the Code of Ethics.

Qualifications and Requirements

• University degree or equivalent professional qualification in Pharmacy, Science, Chemistry, Biology, Engineering, or a related discipline.
• Minimum of 7 years of extensive experience in regulatory affairs for biopharmaceutical products, with significant responsibility for Life Cycle Management, national submissions, labeling, and regulatory CMC activities.
• Experience working across multiple markets, products, and national regulatory requirements within a regional or international environment.
• Strong understanding of post-approval regulatory frameworks, national dossier requirements, health authority procedures, CMC change management, and implementation controls.
• Demonstrated experience leading complex regulatory portfolios and cross-functional matrix teams.
• Ability to collaborate, influence, negotiate, and align local, regional, and global teams, as well as technical and functional partners.
• Excellent written and verbal communication skills in English, including the ability to present technical information, risks, and recommendations to senior stakeholders.
• Ability to make operational decisions, set priorities, and manage complex or ambiguous situations with a high degree of autonomy.
• Ability to evaluate technical and regulatory information, identify gaps, and provide practical, evidence-based recommendations.
• Experience using regulatory information systems, records management tools, submission tracking systems, and regulatory data maintenance processes.

Desirable Capabilities

• Experience leading Centres of Excellence, regional hubs, shared services models, or transformation programs.
• Experience with Veeva RIM, ERV, or other regulatory planning, analytics, and management platforms.
• Experience implementing automation, digital workflows, dashboards, or continuous improvement solutions.
• Experience working with small molecules, biologics, or biotechnology-derived products.
• Experience partnering with Manufacturing, Supply, Quality, Labelling, and other functions involved in post-approval change implementation.

Work Environment

This is a full-time position based in Riyadh, Saudi Arabia. The role operates within a dynamic environment focused on advancing healthcare in KSA, requiring professionals who can thrive amidst change and contribute to shaping the future of healthcare.