Regulatory Affairs Senior Manager, Regional CoE

AstraZeneca · Petaling Jaya, Malaysia

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Role summary

AstraZeneca seeks a Regulatory Affairs Senior Manager to lead lifecycle management activities for a regional center of excellence in Malaysia. The role oversees operational delivery, governance, and performance of regulatory work across multiple markets while maintaining Health Authority relationships and ensuring compliance with international strategies.

What they're looking for

Senior regulatory affairs experience with lifecycle management portfolio leadership
Expertise in CMC change management, dossier customization, and submission strategies
Proven ability to lead matrix teams across countries and manage complex stakeholder relationships
Knowledge of Health Authority question management and post-approval regulatory pathways
Experience with regulatory information systems and compliance with GxP requirements
Demonstrated capability in process standardization, workflow optimization, and team development

What you'll be doing

Lead lifecycle management portfolio delivery, prioritization, and governance across assigned countries and products
Customize and quality-check country-ready dossier packages, including Module 1 and administrative content for submission
Establish collaborative relationships with market-company regulatory leaders, international teams, and cross-functional partners
Oversee Health Authority question tracking, coordinate responses, and manage approval or notification implementation
Drive standardization of workflows, develop playbooks and templates, and lead team capability building and performance management

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