Regulatory Affairs Lead — Shape Access to Medicines in KSA

AstraZeneca GmbH; Riyadh; On-site; SAR 600,000 - 850,000; Full time

Job summary

AstraZeneca is seeking a Regulatory Affairs Lead in KSA to drive regulatory strategies and manage submissions across the product lifecycle. You will partner with local and global teams to ensure compliant, timely access to medicines in the Saudi market.

The role requires senior regulatory experience (9+ years) including multinational exposure, strong knowledge of local and international standards, and proven leadership capabilities within regulatory functions.

Qualifications

• Saudi National
• Higher education in pharmaceuticals, medicine, or biotechnology
• Minimum 9 years in regulatory affairs (drug development, approvals, launches, licenses)
• 5+ years in multinational environment with proven contributions
• Strong knowledge of local and international regulatory standards
• Demonstrated ability to manage pivotal projects and resources
• Excellent collaboration and teamworking across global functions
• Proven people management capabilities
• Strong business acumen, including financial and strategic awareness

Responsibilities

• Drive regulatory strategy and submissions across the product lifecycle.
• Provide regulatory expertise and strategic input to product and project teams.
• Identify regulatory risks and propose mitigation strategies.
• Oversee licenses, registrations, labeling, safety reporting, inspections, and audits.
• Act as primary regulatory contact with SFDA, GHC, and other authorities and update global systems.

Skills

Regulatory strategy

Submissions management

Regulatory compliance

Stakeholder collaboration

Team leadership

Education

Saudi National

Higher education in pharmaceuticals/medicine/biotechnology

Job description

AstraZeneca is seeking a Regulatory Affairs Lead in KSA to drive regulatory strategies and manage submissions across the product lifecycle. You will partner with local and global teams to ensure compliant, timely access to medicines in the Saudi market.

The role requires senior regulatory experience (9+ years) including multinational exposure, strong knowledge of local and international standards, and proven leadership capabilities within regulatory functions.