Executive Director, Promotional Regulatory Affairs

The Executive Director, Promotional Regulatory Affairs is a senior enterprise leader responsible for defining and advancing the regulatory strategy that enables business growth while maintaining the highest standards of compliance, ethics, and scientific integrity. The PRA team are strategic business partners who helps AstraZeneca accelerate innovation, bring medicines to patients responsibly, and create sustainable competitive advantage through trusted, and impactful engagement across the healthcare ecosystem.

Leading a team of promotional regulatory experts across multiple therapeutic areas and business units, this role serves as a strategic advisor to senior and executive leadership, shaping decisions that influence product launches, brand strategy, customer engagement, scientific exchange, and lifecycle management. 

As the leader of the PRA function, this leader drives organizational excellence, modernizes ways of working, advances digital and AI-enabled capabilities, and develops talent to ensure PRA remains a trusted business partner and strategic advantage for AstraZeneca. 

This Executive Director role shapes the regulatory strategy, governance, and organizational capability needed to enable business growth while safeguarding the company reputation, compliance posture, and commitment to patients. 

Key Accountabilities

Enable Business Growth Through Strategic Regulatory Leadership 

• Shape promotional regulatory strategies that enable sustainable business growth, successful product launches, lifecycle optimization, and innovative stakeholder engagement while maintaining the highest standards of compliance. 

• Serve as a trusted advisor to senior and executive leaders, providing strategic counsel on promotional regulations, business risk, emerging regulatory trends, and complex marketplace challenges. 

• Influence enterprise decisions by integrating regulatory perspectives into commercial, medical, and corporate strategies. 

Lead a High-Performing Promotional Regulatory Organization 

• Lead, inspire, and develop a team of PRA professionals supporting multiple therapeutic areas and business units. 

• Foster a culture of accountability, collaboration, innovation, and continuous development that strengthens organizational capability and succession readiness. 

• Build and sustain a diverse, future-ready organization equipped to address evolving business and regulatory needs.

Strengthen Enterprise Governance and Risk Management 

• Ensure consistent application of regulatory standards, governance frameworks, and risk-management practices across promotional and product communications. 

• Lead regulatory assessments and mitigation strategies for high-impact business initiatives, emerging issues, and complex compliance challenges. 

• Guide interactions with regulatory authorities, including OPDP and APLB, representing AstraZeneca with credibility and expertise. 

Drive Operational Excellence and Future-Ready Innovation 

• Champion modernization of PRA processes, operating models, and technologies to improve efficiency, scalability, and effectiveness. 

• Serves as a strategic regulatory partner in the evolution of enterprise omnichannel capabilities, anticipating emerging regulatory considerations and enabling innovation 

• Identify and implement opportunities to employ digital solutions, artificial intelligence, and analytics to enhance decision-making and regulatory operations and increase the efficiency of the end-to-end promotional review process. 

• Establish sustainable, compliant, and agile ways of working that enable the organization to respond effectively to changing business and regulatory demands.

Advance Enterprise Impact and Cross-Functional Collaboration 

• Partner with Commercial, Medical, Legal, Compliance, Market Access, Corporate Affairs, and Global stakeholders to align regulatory strategies with enterprise priorities. 

• Lead and influence cross-functional initiatives with broad organizational impact, driving outcomes that improve customer engagement, operational effectiveness, and regulatory readiness. 

• Act as a visible and influential leader within AstraZeneca and externally, strengthening credibility with key stakeholders and regulatory agencies. 

Essential Experience 

• 10+ years of experience in Regulatory Affairs, Promotional Regulatory Affairs, or a related pharmaceutical/biotechnology discipline, including people leadership responsibility. 

• Deep expertise in FDA promotional regulations, pharmaceutical advertising and promotion, drug development, labeling, post-marketing requirements, and healthcare compliance. 

• Demonstrated success leading regulatory strategy for complex portfolios, product launches, lifecycle management activities, and high-visibility business initiatives. 

• Experience influencing senior executives and cross-functional leaders on complex regulatory, compliance, business, and reputational risk decisions. 

• Proven track record of leading teams through organizational change, transformation, and capability-building initiatives. 

• Experience interacting with regulatory authorities and representing organizations in external regulatory engagements. 

• Preferred experience leading technology-enabled transformation of MLR review processes, including responsible use of AI/intelligent automation to harmonize workflows, strengthen governance, improve review quality, and accelerate compliant content delivery.  

• Demonstrated ability to partner across Medical, Regulatory, Legal, Compliance, Commercial, and technology teams to translate AI opportunities into scalable operating models.