Jobs / Malaysia / Astrazeneca Pharmaceuticals Lp
Regulatory Affairs Senior Manager, Regional CoE
Astrazeneca Pharmaceuticals Lp · 🌍 Malaysia - Petaling Jaya
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About the role
Job description The Regulatory Affairs Senior Manager in the Regional Regulatory CoE leads the operational delivery, governance and performance of LCM activities performed by the CoE on behalf of MC regulatory teams. Building on the accountabilities of an MC Regulatory Affairs Senior Manager, the role ensures that market work is transferred, prioritised and executed through a scalable regional model that reduces local operational workload without weakening local accountability or Health Authority relationships. The role provides senior regulatory and CMC judgement, leads matrix delivery across countries and products, and establishes effective collaboration with MC regulatory leaders, International iRAMs, iRADs and iCMC. The Senior Manager ensures approved international strategies and source content are converted into complete, compliant country-ready packages and progressed through submission, Health Authority questions, approval or notification, implementation and closure. Typical accountabilities · Lead the CoE assigned LCM portfolio and delivery scorecard in alignment with regional and MC business priorities, agreed service levels and compliance expectations. · Own demand intake, prioritisation, work allocation, capacity visibility and delivery governance for LCM activities transferred from participating MC teams. · Lead complex or high-impact dossier customisation and submission delivery, providing expert advice on country requirements, post-approval pathways, CMC change management and operational strategy. · Establish robust working relationships and processes with MC regulatory leaders, International iRAMs, iRADs, iCMC and cross-functional partners to reduce duplication and enable efficient hand-offs. · Ensure CoE teams prepare, compile, quality-check and deliver country-ready LCM packages, including Module 1 and administrative content, using approved international and CMC source materials. · Where applicable, lead the CoE labelling adaptation and implementation capability for assigned products, ensuring the team has the expertise, tools, templates and quality controls to deliver high-volume, multi-market labelling changes accurately and efficiently on behalf of MC teams. · Drive standardization and efficiency in workflows, including template development, country requirement playbooks, artwork coordination processes and automation opportunities, to reduce MC workload and improve right-first-time quality. · Lead or participate in regional and international delivery teams for complex submissions and provide expert regulatory advice on risks, options and mitigations. · Govern Health Authority question management for complex LCM activities, ensuring clear ownership, aligned responses, timely contributions and appropriate escalation to MC or international strategy owners. · Oversee approval or notification tracking, implementation of variations and commitments, and timely, accurate maintenance of RIM, ERV, and other regulatory systems. · Identify potential regulatory, CMC, supply, quality, resource and timeline risks to the regional LCM plan and lead or recommend mitigation actions. · Lead resolution of submission execution failures, portal rejections, administrative non-compliance or timeline breaches, identifying root causes, implementing corrective actions and communicating transparently with MC regulatory leaders and regional leadership. · Lead CoE performance management, including agreed objectives, throughput, timeliness, right-first-time quality, data quality, HAQ cycle time, implementation and closure performance. · Build CoE capability through coaching, knowledge sharing, workload management, development planning and deployment of subject-matter expertise across the team. · Drive best-prac