Senior Manager, Regulatory Affairs - Regional CoE

About the role

AstraZeneca is seeking a Regulatory Affairs Senior Manager to join the Regional Regulatory Centre of Excellence in Riyadh and lead the operational execution of Life Cycle Management (LCM) activities for assigned products across assigned markets. The role combines senior regulatory expertise, technical and CMC judgment, matrix leadership and portfolio management, and helps reduce the operational burden on local teams while keeping Marketing Companies accountable for market decisions and local obligations.

Key responsibilities

• Lead the regional LCM portfolio, aligned with business priorities, service levels and quality and compliance expectations.
• Manage intake, prioritization, work allocation, capacity and governance of activities transferred from Marketing Company teams.
• Lead complex dossiers, regulatory submissions, national requirements, post-approval pathways and CMC change management.
• Prepare, compile and quality-review country-ready regulatory packages, including Module 1, national forms, cover letters, declarations, translations and ERV activities.
• Execute or support submissions, maintain submission evidence and keep regulatory records complete and current.
• Coordinate responses to health authority questions, involving Marketing Companies, iRAMs, iRADs and iCMC.
• Oversee approval follow-up, variation implementation, regulatory system updates and compliant closure.
• Lead regional labeling adaptation and implementation where applicable.
• Design and improve processes, templates, guides, artwork workflows and automation to improve efficiency and right-first-time quality.
• Identify and mitigate regulatory, CMC, supply, quality, resource and timeline risks, and resolve rejections and schedule deviations with root cause analysis.
• Manage performance indicators and coach the team, build relationships with Marketing Companies and partners, and ensure GRP, GxP and AstraZeneca policy compliance.

Required profile

• University degree or equivalent in Pharmacy, Science, Chemistry, Biology, Engineering or a related discipline.
• Minimum 7 years of regulatory affairs experience for biopharmaceutical products, including Life Cycle Management, national submissions, labeling and regulatory CMC.
• Experience across multiple markets and national regulatory requirements in a regional or international setting.
• Demonstrated experience leading complex regulatory portfolios and cross-functional matrix teams.
• Excellent written and verbal English, with autonomy and scientific/regulatory judgment.

Desirable

• Experience leading Centres of Excellence, regional hubs, shared services or transformation programs.
• Veeva RIM, ERV or other regulatory planning and analytics platforms.
• Automation, digital workflows, dashboards or continuous improvement experience.
• Small molecules, biologics or biotechnology products, and partnership with Manufacturing, Supply, Quality and Labelling.