Senior Manager, Regulatory Affairs US Lead

AstraZeneca · Boston, MA +1 more

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RegulatoryFull-time$136k–$203kCompany career page

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Role summary

Senior Manager leading US regulatory strategy and submissions for rare disease products at Alexion (AstraZeneca). Accountable for developing and executing regulatory strategies across pre-approval and lifecycle management stages while serving as primary FDA contact and collaborating with cross-functional teams.

What they're looking for

6+ years pharmaceutical regulatory affairs experience in US jurisdiction
Bachelor's degree in life science; postgraduate degree (MSc, PharmD, PhD) preferred
Strategic regulatory advice across all development stages from pre-approval to marketed products
Ability to manage multiple complex projects simultaneously in time-sensitive environment
Strong interpersonal and presentation skills with proven risk assessment judgment
Knowledge of emerging regulations, GxP requirements, and regulatory information interpretation
Proficiency with Microsoft 365 tools and regulatory documentation systems like Veeva

What you'll be doing

Develop and implement US regulatory strategies for assigned projects and products supporting global objectives
Manage and execute regulatory submissions including INDs, BLAs/NDAs, and orphan drug applications
Serve as primary contact with FDA for regulatory meetings and authority interactions aligned with global strategy
Oversee operational activities ensuring compliance with internal and external regulatory requirements
Provide regulatory input to cross-functional teams on commercial, medical, and business-relevant deliverables

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