Director, Regulatory Affairs

Regenxbio(1 month ago)

Rockville, MDOnsiteFull TimeDirector$195,873 - $261,483 (estimated)Regulatory Affairs

About this role

The Director, Regulatory Affairs at REGENXBIO leads development and execution of global regulatory strategies for early-stage and advanced therapy products. The role oversees preparation of key submissions and alignment with U.S. and international regulatory requirements while closely monitoring evolving regulatory and policy landscapes. The director engages with external stakeholders, professional societies, and consortia to shape development pathways and guidance. This role also builds internal regulatory intelligence resources and partners across functions to support products from pre-IND/CTA through the full product lifecycle.

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Required Skills

Regulatory Strategy
Regulatory Submissions
Global Regulations
Advanced Therapies
Regulatory Intelligence
Stakeholder Engagement
Policy Analysis
Cross Functional Collaboration
Leadership
Problem Solving

+7 more

Qualifications

MD
PhD
MS in Science
MS in Biotechnology
MS in Regulatory
Doctorate Degree

About Regenxbio

ultipro.com

UltiPro (originally from Ultimate Software) is a cloud-based human capital management (HCM) platform that delivers HR, payroll, talent management, and workforce management tools for organizations. The SaaS suite includes payroll processing, benefits administration, recruiting and onboarding, performance management, time & attendance, and people analytics in a unified system. Known for strong customer support and analytics-driven HR workflows, UltiPro was developed by Ultimate Software, which merged with Kronos to form UKG (Ultimate Kronos Group) and continues in that product portfolio (often branded UKG Pro). Enterprises across industries use it to streamline HR operations and improve employee experience.