About the role

Drive global regulatory strategy and submissions for late-stage rare disease therapies at Alexion, AstraZeneca Rare Disease. Lead Health Authority interactions and cross-functional regulatory execution.

Responsibilities

Own and drive regulatory strategy for late-stage or marketed products
Serve as the Regulatory Lead, leading end-to-end regulatory strategy across the US and/or other key global jurisdictions (EU, UK, Canada)
Design and implement submission strategies to support product development, registration, and lifecycle management (INDs, CTAs, BLAs/NDAs, Orphan Drug Designation, pediatric plans)
Lead interactions and meetings with major Health Authorities (FDA, EMA, HC, MHRA), representing Alexion
Act as a strategic partner to Clinical, Medical Affairs, Commercial, and Global Program Teams, providing regulatory input that shapes development plans and product strategy
Lead execution of key submissions and oversee regulatory documentation, timelines, and team deliverables
Collaborate cross-functionally with Regulatory Operations, Labeling, and CMC to ensure alignment and success
Stay current on emerging regulatory trends, guidances, and policy shifts and advocate for regulatory innovation
Support enterprise-level regulatory process development, audit readiness, and inspection response
Provide strategic and tactical mentorship to regulatory colleagues and contribute to team culture

8+ years of experience in Regulatory Affairs within pharma or biotech, including US regulatory strategy and submissions
Proven leadership in global regulatory strategy across the drug development lifecycle, from early development through marketing applications and post-market support
Deep understanding of the drug development process, global regulatory frameworks, and rare disease or specialty drug pathways
Track record of leading meetings with Health Authorities (FDA, EMA, HC, MHRA) and managing complex regulatory submissions
Experience designing and implementing submission strategies including INDs, CTAs, BLAs/NDAs, Orphan Drug Designation, and pediatric plans
Strong working knowledge of GxPs, emerging regulations, and regulatory intelligence tools
Demonstrated ability to think strategically, manage risk, and make sound regulatory judgments in fast-moving environments
Exceptional collaboration and communication skills; ability to influence at all levels including senior leadership

short-term incentive bonus opportunity
eligibility to participate in our equity-based long-term incentive program
qualified retirement program [401(k) plan]
paid vacation and holidays
paid leaves
health benefits including medical, prescription drug, dental, and vision coverage
Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours
Flexible/hybrid work arrangement (on average a minimum of three days per week from the office)