AstraZeneca · 8 hours ago
Executive Director, Global Regulatory Strategy, Policy and Intelligence
Gaithersburg, MD
Full-time
Onsite
Director/Executive
$267K/yr - $401K/yr
10+ years expAstraZeneca is seeking an Executive Director to lead enterprise regulatory strategy on intelligence and external policy across all therapeutic areas. This role aims to accelerate patient access and enhance regulatory excellence globally by utilizing data-driven and AI-enabled regulatory intelligence while partnering across R&D for improved patient outcomes.
BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
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
Ensure integrated, compliant strategies that support optimized market access across the US, Europe, and International
Lead the development and adoption of AZ policies aligned to global frameworks
Build a best-in-class intelligence function using advanced analytics and AI to monitor, synthesize, and communicate global/local trends
Sponsor AI-enabled regulatory workflows and ensure responsible AI practices and compliance
Drive innovative filing strategies to improve authoring consistency and regulatory agility
Partner with Regional Commercial leadership to build future-ready capabilities
Build strong relationships across science units and functions to align regulatory strategy with program objectives
Operate to high standards of regulatory compliance, data integrity, and responsible AI
Represent AZ on internal governance bodies and with key external organizations to shape regulations and guidance
Qualification
Required
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
Preferred
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
Benefits
Short-term incentive bonus opportunity
Equity-based long-term incentive program (salaried roles)
Retirement contribution (hourly roles)
Commission payment eligibility (sales roles)
Qualified retirement program [401(k) plan]
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage
Company
AstraZeneca
AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.26B2024-07-30Post Ipo Debt· $1.51B
2023-02-28Post Ipo Debt· $2.25B
2023-02-24Post Ipo Debt· $1.5B
Leadership Team
Pascal Soriot
Chief Executive Officer
Aradhana Sarin
Group CFO and Executive Director
Recent News
Essential Business
2026-01-24
2026-01-23
Company data provided by crunchbase