Position Summary

Associate Director, Regulatory Affairs (EU/RoW) provides strategic and technical regulatory leadership for the development, registration, commercialization, and lifecycle management of novel therapies in the orphan and rare disease space. As the principal regulatory representative for programs across the European Union and Rest of World, this role develops and executes regional regulatory strategies and leads regulatory interactions with authorities and stakeholders.

Responsibilities

• Provide regulatory strategic insight and procedural expertise as the principal regional liaison.
• Establish regulatory objectives, strategic priorities, and regional plans for assigned programs.
• Ensure regulatory strategies support program milestones, proactively mitigating regulatory risks.
• Assess regulatory risks, evaluate options, and make recommendations that influence timelines and objectives.
• Lead cross‑functional...