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Regulatory Affairs Senior Manager, Regional CoEAstraZeneca · Malaysia - Petaling Jaya
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AstraZeneca

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Regulatory Affairs Senior Manager, Regional CoE

✓ This company has sponsored visas before. The posting doesn't say so, but it's still worth applying.

🗓️ Posted 2026-09-28 Malaysia - Petaling Jaya Full-time Hybrid General
💰 Salary Not shared 📊 Market RM12,000–RM20,000/mo

About the Company

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.

About the Role

oss 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 exper

Requirements

  • ● Extensive biopharmaceutical regulatory experience, including significant responsibility for established-product LCM, country submissions, labelling and regulatory CMC.
  • ● Proven experience leading complex regulatory delivery portfolios and multidisciplinary matrix teams across multiple products or markets.
  • ● Thorough knowledge of post-approval regulatory frameworks, country dossier requirements, Health Authority procedures, CMC change management and implementation controls.
  • ● Advanced portfolio, project, stakeholder, influencing, negotiation, risk-management and problem-solving skills.
  • ● Demonstrated ability to design operating models, manage demand and resources, govern performance, standardise processes and develop regulatory capability.
  • ● Excellent written and verbal English, cultural awareness, scientific judgement and senior-stakeholder communication capability.
  • ● Experience with Veeva RIM, ERV, regulatory intelligence, planning and analytics platforms.
  • ● Experience scaling automation, digital workflows, dashboards, quality systems or continuous-improvement solutions.
  • ● Experience implementing regulatory changes across small molecules, biologics or biotechnology-derived established products and with manufacturing, supply and quality interfaces.
  • ● Key relationships Senior Area Regulatory Director and regional regulatory leadership.
  • ● Marketing Company Regulatory Affairs leaders and Regulatory Country Leads.
  • ● International iRAMs and iRADs.
  • ● iCMC product leads and submission contributors.
  • ● Regional CoE team and cross-functional partners in manufacturing, supply, quality, labelling, patient safety and regulatory operations.
  • ● Local distributors, external service providers and Health Authorities through the agreed MC operating model.
  • ● Date Posted 28-Sep-2026
  • ● Closing Date 28-Okt-2026
  • ● AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.