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

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Senior Regulatory Affairs Specialist, 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 Healthcare Medical
💰 Salary Not shared 📊 Market RM6,000–RM9,000/mo

About the Company

Job description The Senior Regulatory Affairs Specialist in the Regional Regulatory CoE manages the operational delivery of LCM activities for assigned countries or clusters. Building on the typical activities performed within an MC regulatory team, the role carries out agreed dossier preparation, customization, submission coordination and execution where possible (e.g. portal upload, administrative filing), Health Authority query management, regulatory-system maintenance and implementation activities on behalf of MC teams.

About the Role

s, iRADs and iCMC. The CoE uses the approved international regulatory and CMC strategy and source content, applies market-specific requirements, and delivers high-quality, country-ready packages while maintaining clear validation and escalation Typical accountabilities Plan and deliver assigned product LCM activities in line with market plans, agreed priorities, internal objectives, local requirements and applicable global procedures. Prepare, compile and customise submission dossiers, including country-specific Module 1 content, national forms, declarations, cover letters, administrative documents and supporting records. Coordinate CMC and non-CMC content with International iRAMs, iRADs and iCMC; identify package gaps and secure timely, approved source documents and responses. Execute or support timely submission according to the agreed market operating model, including administrative submission steps and submission evidence where applicable. Follow dossiers throughout assessment, monitor milestones, anticipate possible Health Authority questions and coordinate complete, consistent and timely responses with MC and international partners. Obtain and track LCM approvals or notifications and coordinate implementation of variations, renewals, commitments and other post-approval changes, including coordination with PSURs/PBRERs and safety data cut offs in line with local requirements. Coordinate labeling customisation, artwork coor

Requirements

  • ● istry, biology, engineering or a related discipline.
  • ● Relevant biopharmaceutical regulatory experience, including hands-on experience in established-product maintenance and country dossier preparation.
  • ● Knowledge of post-approval submissions, local administrative requirements, Health Authority query management, approval implementation and regulatory data maintenance.
  • ● Ability to work across CMC and non-CMC content and to collaborate effectively with MCs, International iRAMs, iRADs and iCMC.
  • ● Strong project coordination, attention to detail, problem-solving, written communication and stakeholder-management skills.
  • ● Proficiency in English and ability to operate effectively in a multicultural, matrix and high-volume environment.
  • ● Experience supporting multiple markets, clusters, local distributors or external submission partners.
  • ● Experience with digital workflow, reporting, automation or continuous-improvement initiatives.
  • ● Key relationships Marketing Company regulatory teams and Regulatory Country Leads.
  • ● International iRAMs and iRADs.
  • ● iCMC product leads and contributors.
  • ● Regional CoE leadership and colleagues.
  • ● Manufacturing, supply, quality, labelling, patient safety, regulatory operations, local distributors and external service providers.
  • ● Date Posted 28-Sep-2026
  • ● Closing Date 27-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.