US Regulatory Affairs Director, Rare Disease Strategy

AstraZeneca; Boston (MA); Sur place; USD 186 000 - 279 000; Plein temps

Avantages offerts par ce poste

Short-term incentive bonuses

Equity-based awards

Retirement programs

Health, dental, and vision coverage

Résumé du poste

Alexion, part of AstraZeneca’s Rare Disease unit in Boston, seeks a Director of Regulatory Affairs US to drive regulatory strategies for complex products and lead US submissions. You will coordinate with FDA and Global Regulatory teams to align on strategy, timelines, and lifecycle management.

The role requires 8+ years in pharma regulatory affairs with US experience, strong communication and leadership skills, and a deep understanding of evolving regulatory guidelines across US, EU and Canada.

Qualifications

• 8+ years of regulatory experience in the pharmaceutical industry with US regional focus.
• Bachelor's degree in life science required; relevant postgraduate degree preferred (MSc/PharmD/PhD).
• Strong knowledge of drug development and regulatory environment with sound scientific and business judgment.
• Experience providing strategic regulatory advice for US, EU, Canada in global development.
• Ability to manage complex issues and lead multiple projects in a time-sensitive fashion.
• Ability to build intra- and inter-team relationships in a global team.

Responsabilités

• Serve as US Strategy Lead on assigned programs and lead US submissions.
• Represent Alexion as FDA point of contact and manage agency meetings and briefing packages.
• Develop innovative regulatory strategies in collaboration with cross-functional teams.
• Monitor new regulatory requirements and advise product teams on impact to development.
• Maintain exemplary behavior, ethics, and transparency with regulatory authorities.

Connaissances

Regulatory strategy

Cross-functional collaboration

Stakeholder communication

Formation

Bachelor's degree in life science

Postgraduate degree preferred (MSc/PhD/PharmD)

Outils

PowerPoint

Veeva

Description du poste

Alexion, part of AstraZeneca’s Rare Disease unit in Boston, seeks a Director of Regulatory Affairs US to drive regulatory strategies for complex products and lead US submissions. You will coordinate with FDA and Global Regulatory teams to align on strategy, timelines, and lifecycle management.

The role requires 8+ years in pharma regulatory affairs with US experience, strong communication and leadership skills, and a deep understanding of evolving regulatory guidelines across US, EU and Canada.