US Regulatory Affairs Director: Lead Strategic Submissions

Alexion Pharmaceuticals, Inc.; Boston (MA); On-site; USD 186,000 - 279,000; Full time

Benefits offered by this job

Retirement plan

Paid time off

Health/dental/vision insurance

Job summary

Alexion Pharmaceuticals, Inc. in Boston seeks a Director of Regulatory Affairs to lead US regulatory strategy for complex rare-disease programs.

You will craft submission plans, coordinate with FDA, and align regulatory activities with global development goals. You will partner with cross-functional teams across clinical development, quality, and legal to navigate evolving requirements, manage risk, and ensure timely registrations and lifecycle maintenance.

Qualifications

• 8+ years of relevant Regulatory experience in the pharmaceutical industry with US regional regulatory strategies.
• Bachelor's degree in life science; postgraduate degree preferred.
• Strong knowledge of drug development and regulatory environment with sound judgment.

Responsibilities

• Serve as US Strategy Lead on assigned programs and act as submission sub-team lead for US submissions.
• Represent Alexion with FDA, lead agency meetings and briefing package development.
• Develop and direct innovative regulatory strategies across global development teams.
• Monitor regulatory requirements and advise product teams on impact to development programs.
• Maintain ethics and transparency in dealings with regulators and stakeholders.

Skills

US regulatory strategy

Leadership

Regulatory affairs

Cross-functional collaboration

Communication

Education

Bachelor's in life science

Postgraduate degree preferred

Tools

Veeva

Microsoft 365

PowerPoint

Job description

Alexion Pharmaceuticals, Inc. in Boston seeks a Director of Regulatory Affairs to lead US regulatory strategy for complex rare-disease programs.

You will craft submission plans, coordinate with FDA, and align regulatory activities with global development goals. You will partner with cross-functional teams across clinical development, quality, and legal to navigate evolving requirements, manage risk, and ensure timely registrations and lifecycle maintenance.