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

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