Regulatory Affairs Lead

ROLE SUMMARY

The Regulatory Affairs Lead is responsible for driving regulatory strategies and managing submissions across the product lifecycle to ensure compliance with local and global requirements The role provides expert advice on processes and documentation proactively manages regulatory risks and partners with health authorities and internal stakeholders to enable timely patient access to innovative medicines The role reports to the Regulatory Affairs amp Pricing Director and supports the RA agenda through the established RA governance

• Lead submission management and cross-functional teams for complex global regulatory applications
• ensuring compliance with AstraZeneca s submission-ready standards
• Provide regulatory expertise and strategic input to product and project teams
• anticipating Health Authority requirements and guiding submissions-related activities
• Identify potential regulatory risks to global and regional operational plans
• proposing mitigation strategies
• Implement and oversee strategies that improve the quality efficiency and timeliness of submissions
• Manage processes related to product licenses registrations and post-marketing requirements including labeling safety reporting inspections and audits
• Act as the primary regulatory contact with key authorities e g SFDA GHC and ensure timely updates to global systems on regulatory guidelines decrees and communications

• Partner with Business Units and relevant internal stakeholders to support the country regulatory agenda
• under the leadership of the Regulatory Affairs amp Pricing Director
• Conduct regular meetings with local agents regulatory teams to align on outstanding activities and ensure smooth execution
• Foster alignment across therapy area RA managers local agents and global stakeholders on regulatory priorities
• Represent AstraZeneca s regulatory interests in official engagements with authorities and industry forums

• Manage and develop a small team of regulatory professionals
• 1 2 direct reports setting clear objectives coaching and providing growth opportunities
• Promote a culture of collaboration creativity and courageous leadership across teams
• Lead or participate in critical projects ensuring regulatory business needs are integrated into AZ s systems processes and standards

• Build and maintain strong relationships with Regulatory Health Authorities industry representatives and key external partners
• Monitor regulatory policy and industry dynamics proactively advising internal stakeholders on potential impacts
• Support business development activities including proposals reports costing and budgets ensuring alignment with corporate strategy

• Ensure all regulatory activities adhere to AstraZeneca s Code of Ethics corporate policies and local legislation
• Timely reporting of adverse events compliance risks conflicts of interest and health environment-related incidents
• Provide regulatory input for audits inspections recalls and related communications to minimize compliance risks

Only applications in KSA will be considered

Saudi National

Higher education in pharmaceuticals, medicine, or biotechnology.

Minimum 9 years experience in regulatory affairs (drug development, product approval/launch, line extension, license maintenance, or Health Authority experience), including at least 5 years in a multinational environment with proven contributions.

Strong knowledge of local and international regulatory standards, requirements, and industry practices.

Demonstrated ability to manage pivotal projects and resource requirements.

Excellent collaboration and team working skills across global functions.

Proven people management capabilities.

Strong business acumen, including financial and strategic awareness.