Regulatory Affairs Senior Manager, Regional CoE

Role Overview

Regulatory Affairs Senior Manager, Regional Regulatory Centre of Excellence at AstraZeneca. This role is based in the Kingdom of Saudi Arabia and leads operational execution of Life Cycle Management activities for assigned products across assigned markets within the Regional Regulatory Centre of Excellence.

Company Overview

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. AstraZeneca is experiencing significant transformation in the Kingdom of Saudi Arabia, driven by a commitment to advancing healthcare, innovation, and sustainable growth. The organization is investing in talent, digital solutions, and new ways of working to enhance impact on patient outcomes and reinforce leadership in therapeutic areas.

Role Purpose

To lead the regional Life Cycle Management portfolio and operational execution of regulatory activities for assigned products across assigned markets. The role ensures medicines reach patients in a timely, safe, and compliant manner while meeting the highest global regulatory standards. The position contributes to reducing the operational burden on local teams while maintaining Marketing Companies' accountability for market decisions, health authority interactions, and local legal obligations.

Key Responsibilities

Life Cycle Management Portfolio Leadership

• Lead the regional Life Cycle Management portfolio, ensuring alignment with business priorities, agreed service levels, and quality and compliance expectations.
• Manage intake, prioritization, work allocation, capacity visibility, and governance of activities transferred from Marketing Company teams.

Regulatory Execution and Dossier Management

• Lead complex or high-impact activities related to dossier customization, regulatory submissions, national requirements, post-approval pathways, and CMC change management.
• 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.
• Execute or support regulatory submissions under the agreed operating model, maintain submission evidence, and ensure regulatory records remain complete and current.

Health Authority Engagement

• 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 Compliance

• Oversee approval follow-up activities, implementation of variations and commitments, regulatory system updates, and compliant closure of activities.
• Ensure activities are executed in accordance with Good Regulatory Practice (GRP), AstraZeneca policies, GxP requirements, the Code of Ethics, and applicable functional procedures.

Labeling Adaptation

• Lead regional capabilities for labeling adaptation and implementation, ensuring appropriate use of tools, templates, and quality controls where applicable.

Process Improvement and Risk Management

• Design and enhance processes, templates, national requirements guides, artwork coordination workflows, and automation opportunities to improve efficiency and right-first-time quality.
• 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.

Performance Management

• Manage performance indicators related to workload volume, timeliness, right-first-time quality, data quality, response times to health authority questions, implementation, and activity closure.

Leadership and Stakeholder Management

• Provide matrix leadership, coaching, knowledge transfer, development planning, and deployment of specialized expertise within the team.
• Build strong relationships with Regulatory leaders in Marketing Companies, iRAMs, iRADs, iCMC, and partners across Manufacturing, Supply, Quality, Labelling, Patient Safety, and Regulatory Operations.

Qualifications & Experience

• University degree or equivalent professional qualification in Pharmacy, Science, Chemistry, Biology, Engineering, or a related discipline.
• Minimum 7 years of extensive experience in regulatory affairs for biopharmaceutical products, including significant responsibility for Life Cycle Management of assigned products, national submissions, labeling, and regulatory CMC activities.
• Experience working across multiple markets, products, and national regulatory requirements within a regional or international environment.
• Demonstrated experience leading complex regulatory portfolios and cross-functional matrix teams.

Skills & Competencies

• Strong understanding of post-approval regulatory frameworks, national dossier requirements, health authority procedures, CMC change management, and implementation controls.
• 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, with the ability to present technical information, risks, alternatives, 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.

Additional Information

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.

Organizational Culture

AstraZeneca is dedicated to being a Great Place to Work where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. An inclusive culture champions diversity and collaboration and is always committed to lifelong learning, growth, and development. AstraZeneca embraces diversity and equality of opportunity and is committed to building an inclusive and diverse team representing all backgrounds. The organization considers applications from all qualified candidates regardless of their characteristics and complies with all applicable laws and regulations on non-discrimination in employment and recruitment.