Regulatory Affairs Lead - Egypt

Job Title: Regulatory Affairs Lead - Egypt

Introduction to role:

Are you ready to turn evolving policy into decisive regulatory strategy that accelerates patient access and strengthens our scientific leadership? As a Regulatory Affairs Lead at AstraZeneca, you will shape registration pathways, guide agency interactions, and translate complex policy changes into clear, proactive plans that deliver real-world impact. You will lead across development and post-approval stages, partnering with medical, legal, market access, government affairs, and commercial colleagues to align global ambition with local realities. In this role, your voice will help secure timely approvals, robust labels, and sustainable access for patients who need our medicines most. Can you see yourself influencing decisions at the intersection of science, policy, and patient outcomes?

Accountabilities:

• Regulatory Strategy Leadership: Define and drive end-to-end regulatory strategy for assigned products, pipeline assets, or therapeutic areas, delivering clear pathways from development through lifecycle management.

• Policy Scouting and Interpretation: Continuously monitor and assess emerging guidelines and external trends, anticipating their impact on submissions, approvals, labeling, lifecycle plans, and market access.

• Business Translation and Action Planning: Convert regulatory and health policy developments into actionable recommendations and prioritized plans that enable fast, compliant decision-making.

• Policy Positions and Advocacy Materials: Support creation of internal policy positions, consultation responses, and briefing materials to inform leadership and shape external dialogue.

• Cross-Functional Partnership: Partner closely with global, regional, and local teams—medical, legal, market access, government affairs, and commercial—to build aligned strategies and unified execution.

• Governance and External Representation: Represent regulatory perspectives in internal governance and selected external interactions, ensuring balanced, evidence-led positions.

• Submission and Agency Engagement: Lead preparation and review of high-quality regulatory submissions and correspondence; plan and execute agency interaction strategies to secure optimal outcomes.

• Compliance and Governance Alignment: Ensure regulatory plans and activities adhere to applicable regulations, internal governance, and ethical standards, embedding quality by design.

• Risk and Opportunity Management: Identify regulatory risks and opportunities early and propose mitigation or acceleration strategies that protect timelines and value.

• Executive Support and Intelligence: Provide leadership with regulatory intelligence, policy analysis, and strategic recommendations that guide portfolio and investment choices.

Essential Skills/Experience:

• Significant experience in regulatory affairs within the pharmaceutical, biotechnology, or healthcare industry.

• Demonstrated experience or strong exposure to regulatory policy, health policy, or policy interpretation.

• Direct experience with multiple health authorities.

• Strong knowledge of registration pathways and regulatory frameworks.

• Experience engaging with cross-functional stakeholders and influencing decisions in a matrix environment.

• Strong written and verbal communication skills, including preparation of briefing documents, regulatory justifications, and strategic recommendations.

• Ability to assess complex regulatory and policy changes and convert them into practical action plans.

• Strong understanding of compliance, governance, and ethical standards in a regulated environment.

Desirable Skills/Experience:

• Advanced degree in a relevant scientific discipline (e.g., PharmD, PhD, MSc) or equivalent experience.

• Proven impact across both development and post-approval lifecycle management, including labeling and variations.

• Exposure to pricing and reimbursement policy and the interfaces between regulatory outcomes, value evidence, and access strategies.

• Experience drafting consultation responses and contributing to industry working groups or trade associations.

• Success influencing across complex global matrices and leading virtual teams without direct authority.

• Proficiency with regulatory intelligence tools and data analysis to inform strategy.

• Fluency in English.

Why AstraZeneca: Here, regulatory experts sit shoulder to shoulder with scientists, policy leaders, and market shapers to turn breakthrough science into therapies that reach diverse patients at speed. We bring global and local perspectives together, using data and storytelling to navigate health systems with precision and integrity. You will join a collaborative culture that values kindness alongside ambition, where trust and empowerment allow you to test bold ideas and learn fast. Your expertise will help connect the dots across the healthcare ecosystem—accelerating launches, shaping policy, and ensuring our innovations translate into sustainable, real-world impact for patients.

Call to Action: Step into a role where your regulatory acumen shapes strategy, speeds access and leaves a lasting mark on patient lives—make your move today!

Date Posted

Closing Date

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.