Orchard Therapeutics

Compliance

• Serve as US Regulatory Science subject matter expert and senior advisor to program regulatory teams; define Orchard’s US regulatory strategies across the pipeline.
• Collaborate closely with assigned US Regulatory lead, European peers, Regulatory CMC team and VP of Regulatory Science to ensure consistent global regulatory approaches.
• Lead/oversee preparation and review of meeting requests, briefing documents and strategic regulatory filings; prepare cross-functional teams for meetings and interface with US regulatory authorities (FDA).
• Ensure coherent communications and strong relationships with FDA; anticipate FDA reactions, interpret and assess impact of Agency requests and prepare actionable response plans.
• Lead US regulatory intelligence and regulatory policy activities: monitor, identify, assess, analyze impact and disseminate relevant regulatory updates; participate in industry associations to advocate on US regulation affecting Orchard’s portfolio.
• Hold line management responsibilities; support VP of Regulatory Science in management of Regulatory Science resources and budget across programs and oversight of third-party vendors.
• Ensure team adherence to GxP and Orchard policies/SOPs; participate in regulatory department AOP and budget adherence.
• Monitor program progress, develop contingency plans, and ensure effective cross-functional collaboration with Clinical, Non-Clinical and Tech Ops/CMC departments.
• Participate in business development initiatives when relevant; travel internationally (mostly UK/EU) as required.

Executive Director, Regulatory Science