Regulatory Affairs Lead

Regulatory Affairs Lead – Driving Innovation and Compliance at AstraZeneca Saudi Arabia

AstraZeneca is a global biopharmaceutical leader dedicated to transforming lives through groundbreaking medicines and therapies for some of the world’s most challenging diseases. As part of our strategic expansion in the Kingdom of Saudi Arabia, we are shaping the future of healthcare in alignment with Saudi Vision 2030, fostering innovation, and delivering sustainable impact. Our operations in KSA are evolving rapidly, driven by cutting-edge technology, collaborative partnerships, and a commitment to advancing patient access to life-changing treatments. This dynamic environment seeks a Regulatory Affairs Lead—a strategic thinker and regulatory expert—to spearhead compliance initiatives, drive regulatory excellence, and ensure seamless alignment with global and local health authority requirements.

In this pivotal role, you will serve as the strategic architect of AstraZeneca’s regulatory affairs in KSA, bridging the gap between scientific innovation, regulatory excellence, and commercial success. Reporting directly to the Regulatory Affairs & Pricing Director, you will lead cross-functional teams, manage high-impact submissions, and champion a culture of compliance, collaboration, and continuous improvement. This position is ideal for a seasoned professional with a passion for regulatory strategy, stakeholder engagement, and shaping the future of healthcare in the region.

Key Responsibilities

Your role will encompass a broad spectrum of strategic, operational, and leadership responsibilities:

• Regulatory Strategy & Submission Leadership
  - Lead the development and execution of robust regulatory strategies for complex global and regional submissions, ensuring full compliance with AstraZeneca’s submission-ready standards.
  - Provide expert guidance to product and project teams, anticipating regulatory requirements from health authorities (such as SFDA and GHC) and aligning submissions with global and local guidelines.
  - Identify and mitigate regulatory risks proactively, proposing data-driven mitigation strategies to safeguard operational plans and timelines.
  - Optimize submission processes to enhance quality, efficiency, and timeliness, ensuring seamless approvals and market access for innovative therapies.
  - Oversee all aspects of product licensing, registrations, and post-marketing obligations, including labeling, safety reporting, inspections, and audits, to maintain compliance and operational excellence.
• Stakeholder Collaboration & Business Partnering
  - Act as the primary regulatory liaison with key health authorities, ensuring real-time updates on regulatory guidelines, decrees, and communications are integrated into global systems.
  - Partner closely with Business Units and internal stakeholders to align the country’s regulatory agenda with AstraZeneca’s broader strategic objectives.
  - Facilitate regular engagement with local agents’ regulatory teams, ensuring alignment on critical activities and fostering smooth execution of regulatory timelines.
  - Represent AstraZeneca in official engagements with health authorities and industry forums, advocating for regulatory best practices and fostering strong external relationships.
• Team Leadership & Talent Development
  - Manage and mentor a small team of regulatory professionals (1–2 direct reports), setting clear performance objectives and fostering a culture of growth and development.
  - Promote collaborative leadership, encouraging innovation and courageous decision-making across teams to drive regulatory excellence.
  - Lead or contribute to high-impact projects, ensuring regulatory considerations are seamlessly integrated into AstraZeneca’s systems, processes, and global standards.
• External Engagement & Business Insight
  - Build and maintain strategic relationships with Regulatory Health Authorities, industry partners, and external stakeholders to stay ahead of regulatory trends.
  - Monitor evolving regulatory, policy, and industry dynamics, providing actionable insights to internal stakeholders on potential impacts and opportunities.
  - Support business development initiatives, including regulatory proposals, costing, and budgeting, ensuring alignment with corporate strategy and market access goals.
• Governance & Compliance
  - Ensure all regulatory activities adhere to AstraZeneca’s Code of Conduct, internal policies, and global regulatory standards, maintaining the highest ethical and operational integrity.
  - Drive continuous improvement in regulatory processes, leveraging best practices to enhance compliance and operational efficiency.

This role is a fantastic opportunity for a Regulatory Affairs Lead to make a meaningful impact in a fast-growing market, contributing to AstraZeneca’s mission of improving patient outcomes while advancing our commitment to Saudi Vision 2030. If you are a strategic thinker with a passion for regulatory excellence and a desire to shape the future of healthcare in KSA, we invite you to join our team and be part of this transformative journey.