Regional Regulatory LCM Leader (CoE)

AstraZeneca plc; Riyadh; On-site; SAR 350,000 - 520,000; Full time

Job summary

AstraZeneca plc in Saudi Arabia seeks a Regulatory Affairs Senior Manager to join the Regional Regulatory Centre of Excellence and lead Life Cycle Management for assigned products across markets. The role requires senior regulatory expertise, CMC judgment, and matrix leadership to drive scalable operating models.

The position focuses on reducing local team workload while maintaining accountability for market decisions, health authority interactions, and regulatory compliance within a fast‑moving

Qualifications

• Minimum 7 years of regulatory affairs experience for biopharmaceutical products.

Responsibilities

• Lead regional Life Cycle Management (LCM) activities across markets.
• Coordinate health authority questions and ensure timely responses.
• Oversee dossier preparation, submissions, and post-approval changes.
• Manage governance, risk, and performance metrics for regulatory operations.
• Provide matrix leadership and capability building across teams.

Skills

Regulatory leadership

Cross-functional leadership

English communication

Autonomy

Regulatory strategy

Regulatory execution

Risk management

Portfolio governance

Regulatory data systems

Education

University degree in Pharmacy, Science, Chemistry, Biology, Engineering, or related discipline

Tools

Veeva RIM

ERV

Regulatory submission systems

Job description

AstraZeneca plc in Saudi Arabia seeks a Regulatory Affairs Senior Manager to join the Regional Regulatory Centre of Excellence and lead Life Cycle Management for assigned products across markets. The role requires senior regulatory expertise, CMC judgment, and matrix leadership to drive scalable operating models.

The position focuses on reducing local team workload while maintaining accountability for market decisions, health authority interactions, and regulatory compliance within a fast‑moving