Senior Regulatory Affairs Specialist, Regional CoE

AstraZeneca · Petaling Jaya, Malaysia

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Role summary

Senior Regulatory Affairs Specialist manages life-cycle maintenance activities for assigned countries within AstraZeneca's Regional Regulatory Centre of Excellence. The role delivers dossier preparation, submission coordination, Health Authority interactions, and post-approval implementation across multiple markets.

What they're looking for

University degree in pharmacy, science, chemistry, biology, or related discipline
Hands-on biopharmaceutical regulatory experience with established-product maintenance
Knowledge of post-approval submissions, administrative requirements, and Health Authority query management
Ability to work across CMC and non-CMC regulatory content
Strong project coordination, attention to detail, and written communication skills
Fluent English proficiency and multicultural collaboration capability

What you'll be doing

Plan and deliver assigned product life-cycle management activities aligned with market plans and local requirements
Prepare, customize and compile submission dossiers including country-specific content and administrative documents
Coordinate content with international teams; monitor assessment milestones and manage Health Authority queries
Execute submissions, track approvals, and coordinate implementation of post-approval changes and variations
Maintain regulatory information systems and provide transparent status reporting to market colleagues and leadership

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