Alexion Pharmaceuticals, Inc. · 20 hours ago
Executive Director, Global Regulatory Strategy, Policy and Intelligence
Gaithersburg, Maryland, United States of America
Full-time
Onsite
Director/Executive
$267K/yr - $401K/yr
10+ years expAlexion Pharmaceuticals, Inc. is seeking an Executive Director to lead enterprise regulatory strategy on intelligence and external policy across all therapeutic areas. This role focuses on accelerating patient access and elevating regulatory excellence globally through innovative development pathways and data-driven regulatory intelligence.
BiotechnologyHealth CareMedicalTherapeutics
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. Partner closely with therapy area regulatory teams and marketing companies to translate strategy into execution
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
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
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
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
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
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
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
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
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
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)
Drive enterprise policy initiatives shaping global expectations for AI/ML in products and processes, RWE acceptability, digital health, decentralized research, and advanced modalities
Ensure regulatory strategies enable timely, equitable access aligned to payer evidence needs and regional HTA expectations
Deliver timely horizon scanning, scenario planning, and actionable guidance for portfolio and program teams
Influence through industry memberships and leadership roles; cultivate relationships with agencies to explore novel pathways and pilots
Ensure work meets SHE, compliance, data privacy, and responsible AI standards; continuously improve efficiency, effectiveness, and audit readiness globally and locally
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 in accordance with the terms and conditions of the applicable plans
Company
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.
1001-5000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO
Leadership Team
Frederic Chereau
SVP, Strategy and Business Development
Imran Shakur
Director, IRT and Technology Lead
Recent News
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2025-12-20
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