Regulatory Affairs Lead

JOB TITLE

Regulatory Affairs Lead

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

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.

What you’ll do

Regulatory Strategy & Submissions

• 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.

Business Partnering & Country RA Agenda

• Serve as the regulatory contact for the Country Head and Business Unit Directors (BUDs).
• 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.

Leadership & People Development

• 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.

External Engagement & Business Awareness

• 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.

Governance & Compliance

• 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.

Essential for the role

• 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 teamworking skills across global functions.
• Proven people management capabilities.
• Strong business acumen, including financial and strategic awareness.

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.

Where can I find out more?

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