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

Role Overview

Senior Area Regulatory Affairs Director, Middle East and Africa (MEA) at AstraZeneca. The MEA Area comprises Gulf & Pakistan, Saudi Arabia, Turkey, Near East and Maghreb cluster, African cluster, and Egypt.

Role Purpose

Lead all regulatory activities across the Middle East and Africa region to accelerate access to life-changing medicines. Set strategic regulatory direction, support local teams, align with global functions, drive high-quality submissions and accelerated approvals, and serve as a member of the MEA Area Leadership Team and International Regulatory Leadership Team.

Key Responsibilities

Regional Regulatory Planning and Implementation

• Develop and implement the regional regulatory plan to achieve rapid approvals with advantageous labelling.
• Align regulatory plans 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 Marketing Company 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.
• Develop an empowering culture.
• Provide direct people management, coaching and development for the Area Policy and Intelligence Director.
• Foster clear direction, capability, and effective collaboration across broader regulatory delivery activities as organizational needs evolve.

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.

Standards 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.
• Contribute to the development of functional goals, strategies, and improvement objectives as a member of the International Regulatory Leadership Team.

Qualifications & 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 or globally through roles in professional societies or trade organizations.
• Proven leadership and program management experience.

Skills & Competencies

• Ability to think strategically and critically evaluate risks to regulatory activities.
• Strategic Direction: Communicate a clear, aligned vision with focused priorities; interpret and respond proactively to surrounding conditions; remain composed in times of difficulty.
• Strong commercial awareness and cross-cultural capability; able to work independently alongside business and marketing colleagues worldwide.
• Decision Making and Influencing: Make effective, timely decisions amid ambiguity; identify key collaborators; adapt style to secure commitment; build networks inside and outside the organization.
• Leadership: Deliver tough messages while sustaining positive relationships; actively lead performance through coaching and feedback.
• Handling Change: Challenge the status quo and transform organizations for sustainable growth.
• Flexibility and Adaptability: Learn quickly from experiences and adapt to new assignments.
• Concern for People: Champion empowerment and commitment through trust and integrity.

Additional Information

Closing Date: 18 September 2026.

AstraZeneca embraces diversity and equality of opportunity. The company is committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible. Applications are welcomed and considered from all qualified candidates regardless of their characteristics. AstraZeneca complies with all applicable laws and regulations on non-discrimination in employment and recruitment, as well as work authorization and employment eligibility verification requirements.