Senior Regulatory Affairs Leader, Regional Lifecycle Management

AstraZeneca; Riyadh; On-site; SAR 450,000 - 750,000; Full time

Job summary

AstraZeneca in Saudi Arabia is seeking a Regulatory Affairs Senior Manager to lead the Regional Centre of Excellence. You will oversee Life Cycle Management activities for assigned products across markets, shaping strategy, ensuring compliance, and optimizing regulatory processes.

The role requires senior regulatory expertise, CMC judgment, and matrix leadership to reduce local burden while maintaining accountability for market decisions and health authority interactions.

Qualifications

• Minimum 7 years in regulatory affairs for biopharma products.
• Experience leading Life Cycle Management across multiple markets.
• Strong knowledge of national regulatory requirements and CMC.
• Excellent English communication and stakeholder management.

Responsibilities

• Lead regional Life Cycle Management portfolio and ensure alignment with priorities.
• Coordinate submissions, health authority interactions, and timelines.
• Manage resources, budgets, and governance of regional regulatory activities.
• Drive labeling adaptation, documentation quality, and process improvement.
• Coach and develop regulatory staff in a matrix environment.

Skills

Regulatory leadership

Cross-functional collaboration

Strategic planning

Education

Bachelor’s degree in Pharmacy, Science, or related

Tools

Veeva RIM

ERV

Job description

AstraZeneca in Saudi Arabia is seeking a Regulatory Affairs Senior Manager to lead the Regional Centre of Excellence. You will oversee Life Cycle Management activities for assigned products across markets, shaping strategy, ensuring compliance, and optimizing regulatory processes.

The role requires senior regulatory expertise, CMC judgment, and matrix leadership to reduce local burden while maintaining accountability for market decisions and health authority interactions.