Orchard Therapeutics

Compliance

• Act as US regulatory lead on assigned program(s)
• Work in close partnership with the Global Regulatory Lead(s) and under the oversight of the Executive Director, Regulatory Science to provide necessary regulatory inputs to the related cross-functional program teams
• Develop the US regulatory strategy under the oversight of the Executive Director, Regulatory Science, including any innovative procedures to expedite the path to approval, in line with corporate goals, in partnership with the Global Regulatory Lead(s) and the program regulatory team(s)
• Help identify regulatory risks, develop mitigation strategies, and support proactive agency engagement plans.
• Support integrated regulatory planning across clinical, nonclinical and chemistry and manufacturing,
• Execute the US regulatory strategy:
• Be the primary liaison with US regulatory authorities for the assigned program(s)
• Plan, prepare, and review submissions to the FDA, including Orphan designation applications (ODD), Investigational New Drug (IND) applications, Fast Track/RMAT designations, and Pediatric study plans
• Prepare FDA meeting requests, briefing documents, coordinate and prepare cross-functional teams for meetings, and interface with US regulatory authorities
• Coordinate and prepare responses to questions and requests for information from US regulatory authorities
• Ensure that regulatory documents are accurate, complete, compliant with applicable regulatory requirements and prepared in accordance with the defined timelines
• Actively participate in regulatory compliance and regulatory team development:
• Monitor, analyze, and disseminate intelligence on US regulatory matters that may affect ongoing development programs
• Lead the implementation of new US regulations/guidelines applicable and relevant to development programs in close collaboration with the Global Regulatory Lead(s) and relevant functional leads
• Contribute to updates, improvements and development of processes (including new SOPs as applicable) linked to regulatory activities
• Participate in internal audits and future HA inspections
• Share expertise and learning experiences - “grow together” approach within the regulatory team.

Associate Director, Regulatory Science