Senior US Regulatory Affairs Manager – Rare Disease Focus

Alexion Pharmaceuticals; Boston (MA); Sur place; USD 109 000 - 164 000; Plein temps

Avantages offerts par ce poste

Short-term incentives

Equity awards

Retirement plan

Health/dental/vision

Paid time off

Résumé du poste

Alexion Pharmaceuticals seeks a Senior Manager, Regulatory Affairs US to lead regulatory strategies and submissions for US programs, guiding development through pre-approval and lifecycle management.

You will partner with cross-functional teams and regulators, drive INDs, BLAs/NDAs, pediatric submissions, and maintain alignment with global strategies while ensuring timely, compliant regulatory deliverables.

Qualifications

• 3+ years of regulatory experience in pharma with US focus.
• Bachelor’s degree required; postgraduate degree preferred.
• Strategic regulatory advisory experience for US development programs.
• Ability to manage multiple projects under tight timelines.
• Strong communication, judgment and cross-functional collaboration.
• Familiar with new and emerging regulations and GxP concepts.

Responsabilités

• Lead US regulatory strategies and submissions for assigned programs.
• Collaborate with cross-functional teams to meet business objectives.
• Interface with US FDA and coordinate regulatory meetings.
• Oversee regulatory operations and compliance for the US.
• Support governance, processes and audit readiness.

Connaissances

US regulatory experience

Regulatory strategy

Cross-functional collaboration

Leadership

Regulatory submissions (INDs/BLAs/NDAs

Formation

Bachelor's degree required

Postgraduate degree preferred

Outils

Veeva

PowerPoint

Microsoft 365

Description du poste

Alexion Pharmaceuticals seeks a Senior Manager, Regulatory Affairs US to lead regulatory strategies and submissions for US programs, guiding development through pre-approval and lifecycle management.

You will partner with cross-functional teams and regulators, drive INDs, BLAs/NDAs, pediatric submissions, and maintain alignment with global strategies while ensuring timely, compliant regulatory deliverables.