Global Regulatory Strategy Lead

Astrazeneca Pharma India Ltd.; Riyadh; On-site; SAR 480,000 - 600,000; Full time

Job summary

AstraZeneca is seeking a Regulatory Affairs Lead in Saudi Arabia to drive regulatory strategies and manage submissions across the product lifecycle. You will provide expert advice, proactively manage regulatory risks, and partner with authorities and internal stakeholders to enable timely patient access to innovative medicines.

You will lead a small team, collaborate with global and local functions, and ensure regulatory compliance across licensing, registrations, and post-marketing

Qualifications

• Saudi National only applications
• Higher education in pharmaceuticals, medicine, or biotechnology
• Minimum 9 years in regulatory affairs with multinational exp
• Strong knowledge of local and international regulatory standards
• Proven ability to manage pivotal regulatory projects and resources
• Excellent collaboration across global functions
• Proven people management capabilities
• Strong business acumen with financial and strategic awareness

Responsibilities

• Lead regulatory strategy and submissions for complex global applications.
• Provide regulatory expertise to product and project teams and anticipate Health Authority requirements.
• Identify regulatory risks and propose mitigation strategies.
• Manage licenses, registrations, post-marketing requirements, labeling, safety reporting, inspections and audits.
• Act as primary regulatory contact with authorities (e.g., SFDA, GHC).
• Partner with BU and internal stakeholders to support country regulatory agenda.
• Foster alignment across RA managers, local agents and global stakeholders on regulatory priorities.
• Represent AstraZeneca regulatory interests in official engagements with authorities and industry forums.
• Lead or participate in projects to integrate regulatory needs into AZ systems, processes and standards.

Skills

Regulatory leadership

Cross-functional collaboration

Stakeholder management

Project governance

Education

Pharma/Med/Bio degree

Job description

AstraZeneca is seeking a Regulatory Affairs Lead in Saudi Arabia to drive regulatory strategies and manage submissions across the product lifecycle. You will provide expert advice, proactively manage regulatory risks, and partner with authorities and internal stakeholders to enable timely patient access to innovative medicines.

You will lead a small team, collaborate with global and local functions, and ensure regulatory compliance across licensing, registrations, and post-marketing