Global Regulatory Affairs Leader — AI-Driven Strategy & Approvals

Alexion Pharma Spain S.L.

Boston (MA)

Hybrid

USD 250,000 - 450,000

Full time

5 days ago

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Job summary

Alexion Pharma Spain S.L. in Boston seeks a VP, Head of Global Regulatory Affairs to shape regulatory strategy across development and commercialization, leading global submissions, labeling, and lifecycle management while interfacing with FDA, EMA, PMDA and other authorities.

The role drives digital transformation in Regulatory Affairs, oversees a high‑performing team, and partners with R&D, Quality, and Commercial to align portfolio decisions with regulatory risk and opportunity, enabling

Qualifications

Advanced degree or equivalent in a scientific field.
20+ years in Global Regulatory Affairs leadership within biopharmaceuticals.
Track record delivering major global approvals across multiple regions.
Deep expertise in rare disease or specialty portfolios.

Responsibilities

Lead global regulatory strategy across development and commercialization.
Oversee global regulatory submissions, labeling strategies, and lifecycle management.
Interface with FDA, EMA, PMDA, and other authorities; manage critical agency interactions.
Drive digital and AI transformation in Regulatory Affairs and data-enabled decision making.
Partner with R&D, QA, Manufacturing, and Commercial to align regulatory plans with portfolio goals.