مدير أول الشؤون التنظيمية، مركز التميز الإقليمي

LCM Portfolio Leadership: Lead the regional Life Cycle Management portfolio, ensuring alignment with business priorities, agreed service levels, and quality and compliance expectations.

Demand and Resource Management: Manage intake, prioritization, work allocation, capacity visibility, and governance of activities transferred from Marketing Company teams.

Operational Strategy and Regulatory Execution: Lead complex or high-impact activities related to dossier customization, regulatory submissions, national requirements, post-approval pathways, and CMC change management.

Dossier Preparation: 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.

Submissions and Tracking: Execute or support regulatory submissions under the agreed operating model, maintain submission evidence, and ensure regulatory records remain complete and current.

Health Authority Questions Management: 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 Closure: Oversee approval follow-up activities, implementation of variations and commitments, regulatory system updates, and compliant closure of activities.

Labeling Adaptation and Implementation: Where applicable, lead regional capabilities for labeling adaptation and implementation, ensuring appropriate use of tools, templates, and quality controls.

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

Risk Management: 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.

Governance and 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 Capability Building: Provide matrix leadership, coaching, knowledge transfer, development planning, and deployment of specialized expertise within the team.

Stakeholder Management: Build strong relationships with Regulatory leaders in Marketing Companies, iRAMs, iRADs, iCMC, and partners across Manufacturing, Supply, Quality, Labelling, Patient Safety, and Regulatory Operations.

Compliance: Ensure activities are executed in accordance with Good Regulatory Practice (GRP), AstraZeneca policies, GxP requirements, the Code of Ethics, and applicable functional procedures.

Desired Candidate Profile

Essential Capabilities

Education: University degree or equivalent professional qualification in Pharmacy, Science, Chemistry, Biology, Engineering, or a related discipline.

Regulatory Experience: 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.

Multinational Experience: Experience working across multiple markets, products, and national regulatory requirements within a regional or international environment.

Technical Knowledge: Strong understanding of post-approval regulatory frameworks, national dossier requirements, health authority procedures, CMC change management, and implementation controls.

Portfolio Leadership: Demonstrated experience leading complex regulatory portfolios and cross-functional matrix teams.

Stakeholder Management: Ability to collaborate, influence, negotiate, and align local, regional, and global teams, as well as technical and functional partners.

Communication: Excellent written and verbal communication skills in English, with the ability to present technical information, risks, alternatives, and recommendations to senior stakeholders.

Autonomy and Professional Judgment: Ability to make operational decisions, set priorities, and manage complex or ambiguous situations with a high degree of autonomy.

Scientific and Regulatory Judgment: Ability to evaluate technical and regulatory information, identify gaps, and provide practical, evidence-based recommendations.

Systems and Data Management: 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.