Regulatory Affairs Director, Egypt

Job Title: Regulatory Affairs Director

Introduction to role:

Are you ready to shape regulatory strategy and policy to speed access to life-changing medicines? This role puts you at the heart of how our science reaches patients, turning complex regulatory landscapes into clear, forward-looking plans that enable confident, timely launches.

You will lead the regulatory agenda, influence authorities and external stakeholders while coaching a high-performing team. Can you see yourself setting the agenda with health authorities and industry bodies, then translating that influence into faster approvals and sustainable access? You will connect cross-functional teams, optimize processes, and turn insight into action—so patients benefit sooner.

Accountabilities:

• Regulatory Strategy and Scorecard: Define and drive the regulatory strategy and scorecard in alignment with cross-functional teams and business priorities; translate strategy into measurable objectives that accelerate approvals and optimize launch readiness.
• Policy Shaping and External Influence: Lead policy-shaping initiatives; identify and progress collaborative projects with health authorities and external stakeholders that reduce barriers and clarify future pathways.
• Industry Representation and Advocacy: Actively represent AstraZeneca in relevant industry working groups; shape and lead the external policy agenda in line with company priorities to strengthen our voice and credibility.
• International Process and Systems Stewardship: Oversee InRex BCs processes in line with international guidance; ensure requirements are communicated to international teams and R3 is consistently updated to maintain high-quality regulatory data.
• Cross-Functional Leadership and Delivery: Lead or participate in global and regional delivery teams for complex submissions, providing expert regulatory advice and guiding health authority briefings to high-quality outcomes.
• Risk Management and Issue Resolution: Anticipate complex regulatory risks to operational plans and propose mitigation options that protect timelines and business objectives.
• Compliance and Governance: Lead GRP procedures and uphold all relevant AstraZeneca policies and cross-functional procedures; ensure disciplined execution throughout the registration lifecycle, including HAQ, through to approvals.
• Stakeholder Engagement: Build and maintain strong relationships with health officials and key external stakeholders to enable constructive dialogue, early insight, and predictable outcomes.
• Capability Building and Team Development: Uplift capabilities across the regulatory team; develop and coach colleagues, enhance ways of working, and contribute to a culture of continuous improvement and efficient operations.
• Intelligence and Communication: Keep leaders and stakeholders informed on registration status and regulatory changes at MOH; ensure timely, objective updates that support decision-making and alignment.

Essential Skills/Experience:

• Advanced degree in life sciences, pharmacy, medicine, or a related discipline
• At Least 15 years’ Regulatory Experience 
• Demonstrated success leading regulatory strategy across multiple therapeutic areas, including specialty products and high-volume launch environments
• Proven track record engaging senior health authority leaders and shaping external policy within complex political and healthcare ecosystems
• Strong negotiation, influencing, and storytelling skills to translate science into clear regulatory and policy narratives
• Experience implementing or optimizing regulatory information management systems and data quality standards
• Leadership with the ability to coach and build diverse, high-performing teams
• Experience managing end-to-end complex submissions, including scientific advice and briefing documents, with predictable timelines and outcomes
• Fluency in English

Desirable Skills/Experience:

• Multinational experience
• Familiar with global pathways and ways of working

Why AstraZeneca:

Join a science-led company where regulatory experts are central to turning discovery into real-world impact. You will work with unexpected teams in the same room—clinicians, market shapers, data scientists, and policy leaders—unleashing bold thinking that clears the path for our innovative pipeline. We operate at pace with trust and empowerment, blending global scale with local agility to navigate evolving expectations and deliver sustainable access for patients. As we expand in specialty care and accelerate a high volume of launches, you will influence systems, not just submissions—growing your craft while advancing medicines that change lives. We value kindness alongside ambition, so you can lead with both courage and care.

Call to Action:

Step into a role where your regulatory leadership shapes access and outcomes—seize this opportunity to set the agenda and deliver faster approvals for patients.

Date Posted

02-مارس-2026

Closing Date

30-مارس-2026

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.