US Regulatory Strategy Director – Rare Diseases

Alexion

Boston (MA)

On-site

USD 186,000 - 279,000

Full time

14 days+

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Job summary

Alexion is seeking a Director of Regulatory Affairs US to lead development and execution of regulatory strategies for US projects and lifecycle management of rare-disease programs. You will partner with global teams and communicate with the FDA, driving submissions and agency meetings.

Based in Boston/ Seaport, you will influence cross-functional decisions and ensure compliant, timely strategies across US and international regulatory environments, supporting patients with unmet medical needs.

Qualifications

8+ years of regulatory experience in the pharmaceutical industry with US regional regulatory strategies.
Bachelor's degree in life science required; relevant postgraduate degree preferred.
Strong knowledge of drug development and regulatory environment with strong scientific and business judgment.
Experience providing strategic regulatory advice in US, EU, Canada for global development.
Ability to manage complex issues and lead multiple projects in a time-sensitive fashion.
Ability to build intra- and inter-team relationships and collaborate in a global team.
Strong interpersonal, written/verbal communication and presentation skills.
Familiarity with new regulations and GxP knowledge.

Responsibilities

Serve as US Strategy Lead on assigned programs and act as submission sub-team lead for US submissions.
Represent Alexion as point contact with FDA, including leading Agency meetings and briefing package development.
Develop and direct innovative regulatory strategies in collaboration with global teams.
Monitor new regulatory requirements or guidance and advise product teams of impact.
Maintain exemplary ethics and transparency in communications with regulators and team members.