Senior Regulatory Affairs Lead - Regional CoE (LCM)

AstraZeneca (Malaysia); Selangor; Sur place; MYR 120 000 - 180 000; Plein temps

Résumé du poste

AstraZeneca Malaysia is seeking a Senior Regulatory Affairs Specialist within the Regional CoE to lead end-to-end lifecycle management activities for designated markets. The role involves preparing and customizing submission dossiers, coordinating with International iRAMs/iRADs/iCMC, and ensuring timely regulatory responses across multiple countries.

You will work closely with MC regulatory teams and leverage the global strategy to deliver country-ready packages, maintain regulatory records, and

Qualifications

• University degree in pharmacy, science, chemistry, biology, engineering or a related discipline.
• Hands-on regulatory experience in established-product maintenance and country dossiers.
• Ability to collaborate with MCs and International iRAMs/iRADs/iCMC; strong English proficiency.

Responsabilités

• Plan and execute LCM activities for assigned markets.
• Coordinate country dossiers and translation where required.
• Manage Health Authority queries and regulatory records.
• Track approvals and post-approval changes; ensure timely responses.

Connaissances

Regulatory experience

Dossier preparation

Cross-functional collaboration

English proficiency

Formation

University degree in pharmacy/ science / chemistry / biology / engineering or related discipline

Outils

Veeva RIM

ERV

Regulatory platforms

Description du poste

AstraZeneca Malaysia is seeking a Senior Regulatory Affairs Specialist within the Regional CoE to lead end-to-end lifecycle management activities for designated markets. The role involves preparing and customizing submission dossiers, coordinating with International iRAMs/iRADs/iCMC, and ensuring timely regulatory responses across multiple countries.

You will work closely with MC regulatory teams and leverage the global strategy to deliver country-ready packages, maintain regulatory records, and