Executive Director, Global Regulatory Strategy, Policy and Intelligence

AstraZeneca•Gaithersburg, MD

About The Position

AstraZeneca is seeking an Executive Director to lead enterprise regulatory strategy on intelligence and external policy across all therapeutic areas. This leader will accelerate patient access, enable innovative development pathways, and elevate regulatory excellence globally by advancing data-driven, AI-enabled regulatory intelligence, shaping emerging frameworks for novel modalities and evidence, and partnering across R&D to deliver differentiated outcomes for patients and the business. What you’ll do Leadership and Strategy : Set a clear vision for Global Regulatory Strategy, Policy and Intelligence, leveraging digital, data, and AI to anticipate and respond to the evolving regulatory landscape. Partner closely with therapy area regulatory teams and marketing companies to translate strategy into execution. Global Market Access Enablement : Ensure integrated, compliant strategies that support optimized market access across the US, Europe, and International. For International markets, collaborate with International Regulatory, Commercial, Medical, Market Access, and Health Economics teams on innovative, risk-based, and regionally tailored filing strategies aligned to commercial and patient access objectives. External Policy Influence : Lead the development and adoption of AZ policies aligned to global frameworks. Execute an integrated external influencing strategy, engaging with health authorities, industry consortia, standards bodies, and professional societies on topics including AI/ML in medical products, real-world evidence, decentralized trials, digital health, biomarkers, novel endpoints, and advanced therapeutics. Regulatory Intelligence and Foresight : Build a best-in-class intelligence function using advanced analytics and AI to monitor, synthesize, and communicate global/local trends, guidance, inspection patterns, and stakeholder signals. Ensure rapid translation of intelligence into portfolio strategy, development plans, and risk management with robust tooling and governance across therapy areas and marketing companies. Digital and AI Enablement : Sponsor AI-enabled regulatory workflows (e.g., guidance parsing, requirement mapping, labeling and submission authoring support, risk signal detection). Ensure responsible AI practices, data stewardship, traceability, human oversight, and compliance with evolving expectations. Champion harmonized data standards and automation to improve cycle times, quality, and audit readiness. Submission Excellence and Innovation : Drive innovative filing strategies (e.g., modular/rolling submissions; data packages leveraging real-world evidence, digital endpoints; platform approaches). Promote structured content management, reuse, and analytics to improve authoring consistency and regulatory agility. Capability Building and Talent Development : Partner with Regional Commercial leadership and affiliates to build future-ready capabilities (data literacy, AI fluency, structured authoring, benefit–risk analytics, external engagement). Establish communities of practice, learning pathways, and clear role expectations for local teams. Cross-Functional Partnerships : Build strong relationships across science units and functions (Medical, Access, Digital/Data) to align regulatory strategy with program objectives, manage expectations, and resolve issues in the best interest of patients and the business. Governance, Compliance, and Risk : Operate to high standards of regulatory compliance, data integrity, Safety, Health and Environment (SHE), privacy, and responsible AI. Maintain clear governance for policy setting, intelligence dissemination, and decision-making, with metrics driving continuous improvement. Influence and Representation : Represent AZ on internal governance bodies and with key external organizations to shape regulations and guidance. Contribute to the strategic direction of the global Regulatory Excellence organization and engage EU and International Leadership Teams when required. Accountabilities People and Performance : Lead and develop a high-performing team; establish flexible, responsive processes; set measurable outcomes (time to insight, time to submission, first-cycle approval rate, inspection readiness, AI tool adoption, quality metrics). Policy Leadership : Drive enterprise policy initiatives shaping global expectations for AI/ML in products and processes, RWE acceptability, digital health, decentralized research, and advanced modalities. Market Access Strategy : Ensure regulatory strategies enable timely, equitable access aligned to payer evidence needs and regional HTA expectations. Regulatory Intelligence : Deliver timely horizon scanning, scenario planning, and actionable guidance for portfolio and program teams. External Engagement : Influence through industry memberships and leadership roles; cultivate relationships with agencies to explore novel pathways and pilots. Operating Discipline : Ensure work meets SHE, compliance, data privacy, and responsible AI standards; continuously improve efficiency, effectiveness, and audit readiness globally and locally.

Requirements

Experienced regulatory professional with an advanced degree (PhD, MD, MSc) in a scientific discipline (pharmacy, biological science), law, or equivalent experience.
At least 10 years of experience in global drug development and regulatory affairs across phases and regions, with credibility delivering positive global regulatory outcomes, engaging senior regulators and industry bodies.
Deep understanding of procedures and requirements across major and emerging markets, including evolving guidance on AI/ML-enabled products, RWE, digital health, biomarkers, and platform/advanced modalities.
Demonstrated experience leading multi-region submission strategies and delivering first-cycle approvals, accelerated pathways, or innovative evidence packages.
Proven track record building and leading large, diverse teams; budget ownership; and delivering change programs involving digital transformation or process modernization.
Evidence of proactive external influence (e.g., leadership roles in societies/trade organizations, position papers, or participation in regulatory pilots).
Managing Change : Challenges the status quo and leads transformation, including digital and AI adoption, with measurable impact and robust change management.
Strategic Direction : Sets an aligned vision; anticipates external shifts; uses scenario planning and data-driven insights to prioritize and allocate resources.
Responsible AI and Data Literacy : Understands AI/ML, data governance, model risk, transparency, and human-in-the-loop oversight; ensures compliant, ethical deployment in regulatory workflows.
Systems Thinking : Designs end-to-end, scalable processes for intelligence, authoring, review, submission, and lifecycle management; embeds controls, metrics, and continuous improvement.
Leadership : Builds trust, empowers teams, coaches candidly; fosters inclusion, psychological safety, and growth mindsets to accelerate innovation.
Decision Making : Makes timely, risk-balanced decisions under ambiguity; leverages analytics, expert judgment, and cross-functional input; documents rationale for defensibility.
Influencing Skills : Navigates complex stakeholders; tailors engagement to secure commitment; cultivates networks with agencies, industry bodies, and internal leaders.
Communication : Translates complex regulatory and technical topics (AI, RWE, digital endpoints) into clear guidance for executive and program audiences; drives alignment across regions.
Collaboration and Enterprise Mindset : Operates across boundaries, integrating commercial and access perspectives to optimize enterprise value and patient impact.

Nice To Haves

Experience implementing AI-enabled regulatory tools (structured content/labeling, guidance analytics, submission assembly automation) with documented benefits.
Familiarity with data standards (IDMP, HL7, CDISC), structured content management, and knowledge graphs for regulatory intelligence.
Experience with innovative evidence (external control arms, pragmatic/decentralized trials, digital measures) and HTA alignment.
Prior service on advisory groups, task forces, or consortia related to AI in life sciences, RWE acceptance, or advanced modality regulation.

Responsibilities

Leadership and Strategy : Set a clear vision for Global Regulatory Strategy, Policy and Intelligence, leveraging digital, data, and AI to anticipate and respond to the evolving regulatory landscape. Partner closely with therapy area regulatory teams and marketing companies to translate strategy into execution.
Global Market Access Enablement : Ensure integrated, compliant strategies that support optimized market access across the US, Europe, and International. For International markets, collaborate with International Regulatory, Commercial, Medical, Market Access, and Health Economics teams on innovative, risk-based, and regionally tailored filing strategies aligned to commercial and patient access objectives.
External Policy Influence : Lead the development and adoption of AZ policies aligned to global frameworks. Execute an integrated external influencing strategy, engaging with health authorities, industry consortia, standards bodies, and professional societies on topics including AI/ML in medical products, real-world evidence, decentralized trials, digital health, biomarkers, novel endpoints, and advanced therapeutics.
Regulatory Intelligence and Foresight : Build a best-in-class intelligence function using advanced analytics and AI to monitor, synthesize, and communicate global/local trends, guidance, inspection patterns, and stakeholder signals. Ensure rapid translation of intelligence into portfolio strategy, development plans, and risk management with robust tooling and governance across therapy areas and marketing companies.
Digital and AI Enablement : Sponsor AI-enabled regulatory workflows (e.g., guidance parsing, requirement mapping, labeling and submission authoring support, risk signal detection). Ensure responsible AI practices, data stewardship, traceability, human oversight, and compliance with evolving expectations. Champion harmonized data standards and automation to improve cycle times, quality, and audit readiness.
Submission Excellence and Innovation : Drive innovative filing strategies (e.g., modular/rolling submissions; data packages leveraging real-world evidence, digital endpoints; platform approaches). Promote structured content management, reuse, and analytics to improve authoring consistency and regulatory agility.
Capability Building and Talent Development : Partner with Regional Commercial leadership and affiliates to build future-ready capabilities (data literacy, AI fluency, structured authoring, benefit–risk analytics, external engagement). Establish communities of practice, learning pathways, and clear role expectations for local teams.
Cross-Functional Partnerships : Build strong relationships across science units and functions (Medical, Access, Digital/Data) to align regulatory strategy with program objectives, manage expectations, and resolve issues in the best interest of patients and the business.
Governance, Compliance, and Risk : Operate to high standards of regulatory compliance, data integrity, Safety, Health and Environment (SHE), privacy, and responsible AI. Maintain clear governance for policy setting, intelligence dissemination, and decision-making, with metrics driving continuous improvement.
Influence and Representation : Represent AZ on internal governance bodies and with key external organizations to shape regulations and guidance. Contribute to the strategic direction of the global Regulatory Excellence organization and engage EU and International Leadership Teams when required.
People and Performance : Lead and develop a high-performing team; establish flexible, responsive processes; set measurable outcomes (time to insight, time to submission, first-cycle approval rate, inspection readiness, AI tool adoption, quality metrics).
Policy Leadership : Drive enterprise policy initiatives shaping global expectations for AI/ML in products and processes, RWE acceptability, digital health, decentralized research, and advanced modalities.
Market Access Strategy : Ensure regulatory strategies enable timely, equitable access aligned to payer evidence needs and regional HTA expectations.
Regulatory Intelligence : Deliver timely horizon scanning, scenario planning, and actionable guidance for portfolio and program teams.
External Engagement : Influence through industry memberships and leadership roles; cultivate relationships with agencies to explore novel pathways and pilots.
Operating Discipline : Ensure work meets SHE, compliance, data privacy, and responsible AI standards; continuously improve efficiency, effectiveness, and audit readiness globally and locally.

Benefits

qualified retirement program [401(k) plan]
paid vacation and holidays
paid leaves
health benefits including medical, prescription drug, dental, and vision coverage

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