US Regulatory Lead - Rare Disease & Equity Options

AstraZeneca; Boston (MA); On-site; USD 136,000 - 203,000; Full time

Benefits offered by this job

Incentives

Equity-based awards

Paid time off

Health, dental, and vision

Job summary

Alexion seeks a Senior Manager, Regulatory Affairs US to lead regulatory strategies for US projects, deliver submissions, and liaise with the FDA. You will guide cross-functional teams to meet business objectives in a rapidly evolving regulatory landscape.

You will oversee regulatory operations, support governance, and stay current with regulations while collaborating across functions to drive lifecycle management of rare-disease assets.

Qualifications

• 6+ years of regulatory experience in pharma with US regulatory strategy experience.
• Bachelor’s degree in life science; postgraduate degree preferred.
• Experience providing strategic regulatory advice for US development across all stages including pre-approval and marketed assets.
• Ability to manage multiple projects in a time-sensitive environment.
• Strong collaboration and communication in a global, cross-functional team.

Responsibilities

• Develop and implement regulatory strategies for US projects/products.
• Manage US regulatory submissions (INDs, BLAs/NDAs, etc.) with cross-functional teams.
• Liaise with FDA and plan regulatory meetings.
• Oversee regulatory operations per current requirements.
• Support governance and advisory bodies and regulatory processes.
• Collaborate with Enterprise functions to provide regulatory input.
• Stay updated on regulatory requirements and trends.
• Demonstrate leadership and ethics within the enterprise and with authorities.

Skills

Regulatory strategy

US regulatory

Cross-functional collaboration

Communication skills

Education

Bachelor's in Life Science

Postgraduate degree preferred

Tools

Microsoft 365

PowerPoint

Veeva

Job description

Alexion seeks a Senior Manager, Regulatory Affairs US to lead regulatory strategies for US projects, deliver submissions, and liaise with the FDA. You will guide cross-functional teams to meet business objectives in a rapidly evolving regulatory landscape.

You will oversee regulatory operations, support governance, and stay current with regulations while collaborating across functions to drive lifecycle management of rare-disease assets.