Associate Director, R&D Quality Regulatory & Risk Integration

Responsibilities

• Regulatory Intelligence & Surveillance Process Leadership
• Establish, implement, and continuously mature the RDQ Regulatory Intelligence & Surveillance process and operating model
• Ensure alignment and connectivity with enterprise/global Regulatory Intelligence & Surveillance processes and governance
• Define and maintain RI&S intake, triage, escalation, impact assessment, and governance integration pathways
• Develop sustainable processes for identifying, evaluating, and operationalizing emerging regulatory intelligence within RDQ
• Maintain oversight of regulatory intelligence governance activities, deliverables, and reporting mechanisms
• Quality Risk Management Integration
• Translate external regulatory intelligence and surveillance signals into actionable RDQ quality risk insights and recommendations
• Facilitate risk-based evaluation of emerging regulatory expectations and potential impact to RDQ processes, systems, and operations
• Integrate regulatory intelligence into RDQ quality risk management activities and governance forums
• Partner with stakeholders to assess and escalate significant regulatory or inspection-related risks as appropriate
• Support development of proactive mitigation and readiness strategies based on emerging regulatory trends
• Governance & Leadership Engagement
• Serve as the Quality System Owner and RDQ representative for Regulatory Intelligence & Surveillance governance activities
• Represent RI&S within RDQ governance forums including RDQ QLT, QMR, Monthly Risk Review Forum, and operational governance meetings
• Develop executive-level summaries, trend analyses, and risk insights for leadership review and decision-making
• Support integration of RI&S into broader RDQ governance and operating model initiatives
• Cross-Functional Collaboration & Stakeholder Engagement
• Serve as the RDQ Regulatory Intelligence Champion (RIC) within enterprise RI&S forums and Centers of Excellence
• Build strong partnerships with Quality, Clinical Development, Regulatory Affairs, Global Quality Systems, Inspection Readiness, and other cross-functional stakeholders
• Partner with business functions to support interpretation and operationalization of evolving regulatory expectations
• Facilitate alignment between enterprise intelligence activities and RDQ operational priorities
• Partner with Regulatory Affairs to provide proactive, trusted quality support to enable high-quality execution of day-to-day operations
• Inspection Readiness & Surveillance
• Monitor and assess inspection trends, enforcement actions, health authority focus areas, and evolving industry expectations
• Support proactive inspection readiness efforts through intelligence-driven risk identification and governance integration
• Identify emerging themes and systemic trends that may impact RDQ compliance posture or operational effectiveness
• Support Regulatory Affairs, as needed, in preparing for regulatory inspections (e.g., FDA BIMO inspections)

Requirements

• Required
• Bachelor's degree in Life Sciences or related discipline
• 8+ years of experience in Quality, Regulatory Affairs, Regulatory Intelligence, Quality Risk Management, Clinical Quality, or related GxP functions within the pharmaceutical/biotechnology industry
• Strong knowledge of GxP regulations, inspection

Benefits

Additional Information

Job Description General Position Summary The Associate Director, R&D Quality Regulatory & Risk Integration is responsible for establishing, implementing, and maturing the R&D Quality Regulatory Intelligence & Surveillance (RI&S) process within RDQ and serving as the main quality point of contact for Regulatory Affairs. This role serves as the strategic integration point between external regulatory intelligence, proactive quality risk management, governance processes, and inspection readiness activities across R&D Quality. The role partners closely with Global Regulatory Intelligence & Surveillance functions, RDQ leadership, Quality System Owners, Regulatory Affairs, and other cross-functional stakeholders to ensure emerging regulatory expectations, inspection trends, enforcement actions, and industry signals are proactively translated into actionable RDQ risk, governance, and operational activities. This individual will serve as the RDQ Regulatory Intelligence Champion (RIC) within enterprise Regulatory Intelligence forums and Centers of Excellence and will represent the Regulatory Intelligence Quality System within RDQ governance forums including the RDQ Quality Leadership Team (QLT), Quality Management Review (QMR), Monthly Risk Review Forum, and operational governance meetings. The Associate Director will serve as a quality business partner to Regulatory Affairs functions and be the resource for quality consults, process improvement initiatives, quality events, and inspection readiness activities. This position sits within the R&D Governance & Risk Management organization and plays a key role in advancing proactive, risk-based governance and inspection readiness capabilities across RDQ.

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