Executive Director, Global Regulatory Strategy, Policy and Intelligence US - Gaithersburg - MD

Executive Director, Global Regulatory Strategy, Policy and Intelligence Location: Gaithersburg, MD (US) Overview: reputed company is seeking an Executive Director to reputed company reputed company regulatory strategy on intelligence and external policy across reputed company therapeutic areas. This leader will accelerate patient reputed company, reputed company innovative development reputed company, and reputed company regulatory reputed company 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 reputed company for patients and the business. What you’ll do

• Leadership and Strategy: Set a clear reputed company 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 reputed company Enablement: Ensure integrated, compliant strategies that support optimized market reputed company across the US, Europe, and International. For International markets, collaborate with International Regulatory, reputed company, Medical, Market reputed company, and Health Economics teams on innovative, risk-based, and regionally tailored filing strategies reputed company to reputed company and patient reputed company objectives.
• External Policy Influence: reputed company the development and adoption of AZ policies reputed company 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, reputed company-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, reputed company reputed company, and compliance with evolving expectations. Champion harmonized data standards and automation to improve cycle times, quality, and audit readiness.
• Submission reputed company and Innovation: Drive innovative filing strategies (e.g., reputed company/rolling submissions; data packages leveraging reputed company-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 reputed company leadership and affiliates to build future-reputed company capabilities (data literacy, AI reputed company, structured authoring, benefit–risk analytics, external engagement). Establish communities of practice, learning reputed company, and clear role expectations for local teams.
• Cross-Functional Partnerships: Build strong relationships across science units and functions (Medical, reputed company, 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 reputed company, Safety, Health and Environment (SHE), privacy, and responsible AI. Maintain clear governance for policy setting, intelligence dissemination, and decision-making, with metrics driving reputed company 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 reputed company organization and engage EU and International Leadership Teams reputed company required.

Accountabilities

• People and Performance: reputed company and reputed company a high-performing team; establish flexible, reputed company processes; set measurable reputed company (time to reputed company, time to submission, first-cycle approval reputed company, inspection readiness, AI tool adoption, quality metrics).
• Policy Leadership: Drive reputed company policy initiatives shaping global expectations for AI/ML in products and processes, reputed company acceptability, digital health, decentralized research, and advanced modalities.
• Market reputed company Strategy: Ensure regulatory strategies reputed company timely, reputed company reputed company reputed company 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 reputed company 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.

Minimum Requirements – Education and Experience

• reputed company 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 reputed company, with credibility delivering positive global regulatory reputed company, 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, reputed company, digital health, biomarkers, and platform/advanced modalities.
• Demonstrated experience leading multi-region submission strategies and delivering first-cycle approvals, accelerated reputed company, 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).

Skills and Capabilities

• Managing Change: Challenges the status reputed company and leads transformation, including digital and AI adoption, with measurable impact and robust change management.
• Strategic Direction: Sets an reputed company reputed company; 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 reputed company-in-the-reputed company reputed company; 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 reputed company improvement.
• Leadership: Builds trust, empowers teams, coaches candidly; fosters inclusion, psychological safety, and growth mindsets to accelerate innovation.
• Decision Making: Makes timely, risk-balanced reputed company under ambiguity; leverages analytics, expert judgment, and cross-functional input; documents rationale for defensibility.
• Influencing Skills: Navigates reputed company stakeholders; tailors engagement to secure commitment; cultivates networks with agencies, industry bodies, and internal leaders.
• Communication: Translates reputed company regulatory and technical topics (AI, reputed company, digital endpoints) into clear guidance for executive and program audiences; drives alignment across reputed company.
• Collaboration and reputed company reputed company: Operates across boundaries, integrating reputed company and reputed company perspectives to optimize reputed company value and patient impact.

Preferred Qualifications

• 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 reputed company to AI in life sciences, reputed company acceptance, or advanced modality regulation.

The annual reputed company pay for this position ranges from $267,408 - $401,112 USD annual USD. reputed company pay offered may vary depending on multiple individualized factors, including market location, job-reputed company knowledge, skills, and experience. In reputed company, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a reputed company retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and reputed company coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify reputed company salary (as well as any other discretionary payment or compensation program) at any time, including for reasons reputed company to individual performance, Company or individual department/team performance, and market factors. Date Posted 23-Jan-2026 Closing Date 12-Feb-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to reputed company applicants and employees. In furtherance of that mission, we welcome and consider applications from reputed company reputed company candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding reputed company in the application reputed company. Apply tot his job Apply To this Job