Senior Area Regulatory Affairs Director, Middle East, and Africa (MEA)

Job description

**Introduction to role:** Are you ready to set the regulatory direction across diverse markets and accelerate access to life-changing medicines? In this senior leadership role, you will be the strategic anchor leading all aspects of regulatory activities in Middle East and Africa Area (MEA) consists of Gulf&PK, Saudi, Türkiye, Near East and Maghreb cluster, African cluster and Egypt, support local teams and work with global/international functions to deliver ambitious growth plans. You will take on the role of key account leader for regulatory matters and bring together Marketing Company Regulatory Heads and collaborators from various departments. Your goal is to drive high-quality submissions, accelerated approvals, and consistent execution. You will also be a member of the MEA Area Leadership Team (ALT) and the International Regulatory Leadership Team (inRA LT). Your leadership will help confirm that the right decisions happen fast, challenges are addressed significantly, and patients benefit sooner. You will also build the external environment by developing relationships and lead initiatives in policy development and public engagement. You will guide regulatory interactions to help our medicines move efficiently through complex systems. This is a chance to combine your vision, people leadership, and regulatory expertise to unlock impact at scale. **Accountabilities:** - **Regional Regulatory Planning and Implementation**: Develop and implement the regional regulatory plan to achieve rapid approvals with advantageous labelling. Align the plan to product profiles and market needs. Ensure conflicts and issues are resolved quickly. - **Cross-Market Leadership**: Act as the account lead for regulatory affairs with Area leadership, Marketing Companies, and global functions. Provide leadership to MC Regulatory Heads through a formal dotted line. - **People Leadership and Capability Build:** Lead recruitment, coaching, and talent development of in-market regulatory teams; drive succession planning for key roles and develop an empowering culture - **Policy Strategy and Advocacy:** Define and deliver the Area policy and advocacy plan with Policy and Intelligence leadership, Corporate Affairs, and partners; lead policy-shaping initiatives to anticipate and influence requirements - **External Engagement and Influence:** Establish and develop relationships with health authorities, industry groups, and policy forums; actively represent the company to shape efficient development and regulatory pathways in priority markets - **Regulatory Excellence and Compliance:** Partner with Global Process, Quality and Learning to ensure Good Regulatory Practice standards reflect in-market realities; highlight and address compliance, competency, or capacity concerns with Area and Regulatory leadership - **Health Authority Engagement:** Ensure strong regulatory representation with authorities at key meetings; document agreements clearly and drive follow-through - **Portfolio and Business Support**: Provide regulatory leadership for license-in due diligence, divestments, and withdrawals; ensure inRA therapeutic areas, iCMC, and centralized international regulatory functions deliver timely support to Marketing Companies - **Risk Management and Decision-Making:** Identify regulatory risks and contingencies; communicate proactively to senior leadership and course-correct with urgency - **Digital Transformation:** Lead digital adoption across Marketing Companies to improve regulatory efficiency, consistency, and speed - **Standard and Process Improvement:** Share and embed standards across regional and global teams; lead significant cross-functional process improvements and agency engagement activities to advance the vision of accelerating patient access - **Strategic Alignment**: Partner with commercial and medical colleagues as an equal contributor to business objectives. Ensure regulatory strategies reflect a deep understanding of commercial goals. - **Governance and Representation**: Represent the relevant region in internal and external initiatives, governance forums, and process improvements; maintain the point-of-contact role for issue management and partner concern - **People management:** Provide direct people management, coaching and development for the Area Policy and Intelligence Director, while fostering clear direction, capability, and effective collaboration across broader regulatory delivery activities, as organizational needs evolve - **International Regulatory Leadership Team (inRA LT):** As a member of the LT you will contribute to the development of functional goals, strategies, and improvement objectives **Essential Skills/Experience:** - Degree or equivalent experience in a scientific field, typically pharmacy or a biological science - 10+ years of regulatory drug development experience, including product approvals/launches and therapeutic area expertise - In depth knowledge of regulatory processes - Experience working across multiple regulatory settings such as Global, European, International, Marketing Company or experience at a health authority - Demonstrated experience proactively shaping regulatory frameworks internationally/globally through roles in professional societies or trade organizations - Proven leadership and program management experience - Ability to think strategically and critically evaluate risks to regulatory activities - Strategic Direction: Communicates a clear, aligned vision with focused priorities; interprets and responds proactively to the surrounding conditions; remains composed in times of difficulty - Strong commercial awareness and cross-cultural capability; able to work independently alongside business and marketing colleagues worldwide - Decision Making & Influencing: makes effective, timely decisions amid ambiguity. Identifies key collaborators, adapts style to secure commitment, and builds networks inside and outside the organization - Leadership: delivers tough messages while sustaining positive relationships; actively leads performance through coaching and feedback - Handling Change: challenges the status quo and transforms organizations for sustainable growth - Flexibility & Adaptability learns quickly from experiences and adapts to new assignments - Concern for People: champions empowerment and commitment through trust and integrity **Why AstraZeneca?** You gain real local ownership here while being linked to an international and global network of expertise. We bring unexpected teams into the same room to unlock ambitious thinking, using data and digital tools to move faster with purpose. Lead the regulatory agenda at scale—bring your expertise to AstraZeneca and shape faster, smarter access to medicines that change lives. **Date Posted** 09-Sep-2026 **Closing Date** 18-Sep-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.