Regional Regulatory Affairs Lead – LCM & CoE

AstraZeneca (Malaysia); Selangor; On-site; MYR 360,000 - 480,000; Full time

Job summary

AstraZeneca Malaysia seeks a Regulatory Affairs Senior Manager to lead end-to-end LCM activities within the Regional CoE, ensuring country-ready packages and timely submissions across markets. You will guide governance, strategy transfer, and cross-functional collaboration with MC regulatory leaders, iRAMs, iRADs and iCMC, driving efficiency while maintaining regulatory compliance.

The role requires senior judgement on CMC, labeling changes, and risk mitigation, with autonomy to shape regional

Qualifications

• Extensive biopharmaceutical regulatory experience, including established-product LCM.
• Proven ability to lead complex regulatory delivery portfolios across markets.
• Thorough knowledge of post-approval regulatory frameworks and CMC change management.
• Excellent stakeholder management, negotiation and risk-management skills.

Skills

Excellent written and verbal English

Education

University degree or equivalent professional qualification in pharmacy, science, chemistry, biology, engineering or a related discipline

Tools

Veeva RIM

ERV

Regulatory intelligence platforms

Planning and analytics tools

Job description

AstraZeneca Malaysia seeks a Regulatory Affairs Senior Manager to lead end-to-end LCM activities within the Regional CoE, ensuring country-ready packages and timely submissions across markets. You will guide governance, strategy transfer, and cross-functional collaboration with MC regulatory leaders, iRAMs, iRADs and iCMC, driving efficiency while maintaining regulatory compliance.

The role requires senior judgement on CMC, labeling changes, and risk mitigation, with autonomy to shape regional