Global Regulatory VP: Strategy, Submissions & AI

AstraZeneca GmbH; Boston (MA); Hybrid; USD 350,000 - 750,000; Full time

Job summary

AstraZeneca GmbH in Boston, MA seeks a strategic VP, Head of Global Regulatory Affairs to lead the global regulatory function across development and commercial portfolios. You will define and execute global regulatory strategies enabling approvals, lifecycle management, and worldwide commercialization, while driving digital and AI transformation for data-driven decisions.

As the senior regulatory leader, you will interface with FDA, EMA, PMDA, and other authorities, oversee global submissions,

Qualifications

• Advanced scientific degree required or equivalent preferred.
• 20+ years of leadership in Global Regulatory Affairs.
• Proven record delivering major global approvals and lifecycle expansions.
• Deep expertise across rare disease and/or specialty portfolios.

Responsibilities

• Lead the Global Regulatory Affairs organization and regulatory strategy.
• Oversee regulatory submissions, labeling strategies, and lifecycle management.
• Interface with FDA, EMA, PMDA, and other authorities to negotiate approvals.
• Drive digital and AI transformation within Regulatory Affairs.
• Partner with R&D, Quality, Compliance, and Leadership to ensure compliant, timely decisions.

Skills

Strategic leadership

Regulatory strategy

Global regulatory submissions

Stakeholder management

Digital transformation in Reg Affairs

Education

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

Job description

AstraZeneca GmbH in Boston, MA seeks a strategic VP, Head of Global Regulatory Affairs to lead the global regulatory function across development and commercial portfolios. You will define and execute global regulatory strategies enabling approvals, lifecycle management, and worldwide commercialization, while driving digital and AI transformation for data-driven decisions.

As the senior regulatory leader, you will interface with FDA, EMA, PMDA, and other authorities, oversee global submissions,