Senior Manager, Regulatory Affairs US Lead

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.

Responsibilities

• 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

Requirements

• 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

Compensation: $135,624.80 - $203,437.20 USD Annual base