US Regulatory Strategy Lead for Rare Diseases

Alexion Pharma Spain S.L.; Boston (MA); On-site; USD 109,000 - 164,000; Full time

Job summary

Alexion seeks a Senior Manager, Regulatory Affairs US Lead in Boston or Gaithersburg to shape US regulatory strategies, manage submissions (INDs, BLAs/NDAs) and interact with FDA, ensuring timely registrations and lifecycle management.

You will lead cross-functional teams, balance regulatory requirements with business objectives, and stay current with evolving regulations while enabling global strategy across rare diseases.

Qualifications

• 3+ years of regulatory experience in pharma with US focus.
• Bachelor's degree; postgraduate degree preferred.
• Ability to lead multiple projects and collaborate globally.

Responsibilities

• Develop and implement US regulatory strategies for assigned projects.
• Manage US regulatory submissions (INDs, BLAs/NDAs, orphan designations, pediatric submissions).
• Act as liaison with FDA and coordinate regulatory authority meetings.
• Collaborate with cross-functional teams to align regulatory plans with business objectives.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Education

Bachelor’s degree

Postgraduate degree preferred

Tools

Microsoft 365

PowerPoint

Veeva

Job description

Alexion seeks a Senior Manager, Regulatory Affairs US Lead in Boston or Gaithersburg to shape US regulatory strategies, manage submissions (INDs, BLAs/NDAs) and interact with FDA, ensuring timely registrations and lifecycle management.

You will lead cross-functional teams, balance regulatory requirements with business objectives, and stay current with evolving regulations while enabling global strategy across rare diseases.