Global Regulatory Affairs Leader: Strategy, Submissions & AI

AstraZeneca; Boston (MA); On-site; USD 350,000 - 500,000; Full time

Job summary

AstraZeneca in Boston seeks a visionary VP, Head of Global Regulatory Affairs to define and execute global regulatory strategies across development and commercial portfolios. You will lead agency interactions with FDA, EMA, PMDA, and others, and drive data-driven regulatory intelligence and AI-enabled submissions.

The role requires 20+ years of leadership in regulatory affairs, a PhD/MD/PharmD or equivalent, and a proven record of successful global approvals and lifecycle expansions.

Qualifications

• Advanced degree in life sciences is required.
• 20+ years of leadership experience in Global Regulatory Affairs.
• Proven track record delivering major global approvals.
• Experience with rare disease and/or specialty biopharmaceutical portfolios.
• Strong FDA/EMA/PMDA engagement experience.
• Experience sponsoring digital transformation in Regulatory Affairs.
• Ability to influence enterprise governance and portfolio decisions.

Responsibilities

• Lead the Global Regulatory Affairs organization and establish regulatory strategy aligned with corporate and portfolio objectives.
• Provide strategic regulatory leadership across all stages of development, from early research through commercialization and lifecycle management.
• Oversee global regulatory submissions, approvals, labeling strategies, maintenance activities, and regulatory compliance.
• Serve as the primary regulatory representative with FDA, EMA, PMDA, and other global health authorities, leading critical agency interactions and negotiations.
• Ensure regulatory risks, opportunities, and strategies are effectively integrated into portfolio, investment, and development decisions.
• Partner with R&D, Medical, Commercial, Quality, Manufacturing, and Executive Leadership teams to drive successful global development and registration outcomes.
• Build, develop, and retain a high-performing global regulatory organization while ensuring effective resource allocation and succession planning.
• Lead the digital and AI transformation of Global Regulatory Affairs, including regulatory information management, automation, data governance, advanced analytics, and AI-enabled regulatory intelligence and submission capabilities.
• Partner with Digital, IT, Data Science, Quality, Compliance, and business leaders to ensure responsible adoption of digital tools and AI, with appropriate standards for data quality, privacy, transparency, validation, inspection readiness, and regulatory compliance.
• Represent the company externally through regulatory agencies, industry associations, and key scientific and policy forums.

Skills

Strategic regulatory leadership

Global regulatory submissions

FDA/EMA/PMDA engagement

Regulatory intelligence

Digital transformation in Regulatory

People leadership

Cross-functional collaboration

Education

Advanced scientific degree (PhD/PharmD/MD/MS)

Job description

AstraZeneca in Boston seeks a visionary VP, Head of Global Regulatory Affairs to define and execute global regulatory strategies across development and commercial portfolios. You will lead agency interactions with FDA, EMA, PMDA, and others, and drive data-driven regulatory intelligence and AI-enabled submissions.

The role requires 20+ years of leadership in regulatory affairs, a PhD/MD/PharmD or equivalent, and a proven record of successful global approvals and lifecycle expansions.