Regulatory Affairs Lead📣 إعلان

About AstraZeneca

AstraZeneca is a global biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines for serious diseases. The company is committed to advancing healthcare and innovation.

The Regulatory Affairs Lead Role

The Regulatory Affairs Lead is responsible for developing and implementing regulatory strategies and managing submissions throughout the product lifecycle. This role ensures compliance with local and global requirements, provides expert advice on regulatory processes and documentation, and proactively manages regulatory risks. The Lead will partner with health authorities and internal stakeholders to facilitate timely patient access to medicines. This full-time position reports to the Regulatory Affairs & Pricing Director.

Key Responsibilities

• Lead submission management and cross-functional teams for complex global regulatory applications, ensuring compliance with AstraZeneca’s submission standards.
• Provide regulatory expertise and strategic input to product and project teams, anticipating Health Authority requirements.
• Identify potential regulatory risks to global and regional operational plans and propose mitigation strategies.
• Implement and oversee strategies to improve the quality, efficiency, and timeliness of submissions.
• Manage processes related to product licenses, registrations, and post-marketing requirements, including labeling and safety reporting.
• Act as the primary regulatory contact with key authorities (*, SFDA, GHC) and ensure timely updates to global systems on regulatory guidelines.
• Partner with Business Units and internal stakeholders to support the country regulatory agenda.
• Conduct regular meetings with local agents’ regulatory teams to align on activities.
• Foster alignment across therapy area RA managers, local agents, and global stakeholders on regulatory priorities.
• Represent AstraZeneca’s regulatory interests in engagements with authorities and industry forums.
• Manage and develop a small team of regulatory professionals (1–2 direct reports), setting objectives and providing growth opportunities.
• Lead or participate in critical projects, ensuring regulatory business needs are integrated into AZ’s systems and processes.
• Build and maintain relationships with Regulatory Health Authorities, industry representatives, and external partners.
• Monitor regulatory, policy, and industry dynamics, advising internal stakeholders on potential impacts.
• Support business development activities, including proposals, reports, costing, and budgets.
• Ensure all regulatory activities adhere to AstraZeneca’s Code of Ethics, corporate policies, and local legislation.
• Provide timely reporting of adverse events, compliance risks, and health/environment-related incidents.
• Provide regulatory input for audits, inspections, recalls, and related communications.

Qualifications and Requirements

• Nationality: Saudi National.
• Education: Higher education in pharmaceuticals, medicine, or biotechnology.
• Experience: Minimum of 9 years 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.
• Knowledge: Strong understanding of local and international regulatory standards, requirements, and industry practices.
• Project Management: Demonstrated ability to manage pivotal projects and resource requirements.
• Collaboration: Excellent collaboration and teamwork skills across global functions.
• Leadership: Proven people management capabilities.
• Business Acumen: Strong business acumen, including financial and strategic awareness.

Work Environment

AstraZeneca in the Kingdom of Saudi Arabia is undergoing a significant transformation focused on advancing healthcare and sustainable growth. The company is investing in talent, digital solutions, and new ways of working to enhance its impact on patient outcomes. This dynamic environment requires agile professionals motivated to shape the future of healthcare in KSA. Only applications from candidates located in KSA will be considered.

Commitment to Development

AstraZeneca fosters an inclusive culture that champions diversity and collaboration, committed to lifelong learning, growth, and development for its employees.