Associate Director, R&D Quality Regulatory & Risk Integration

Associate Director leads the RDQ RI&S process, establishing and maturing the Regulatory Intelligence & Surveillance model and serving as the main quality contact for Regulatory Affairs. Acts as the RI&S champion within enterprise forums, translating external regulatory signals into actionable RDQ risk and governance actions, and partnering with Regulatory Affairs and other cross-functional stakeholders to ensure inspection readiness and proactive quality improvements across R&D Governance & Risk Management. Key responsibilities include leadership of RI&S processes, integration with enterprise RI&S, governance participation (QLT, QMR, Monthly Risk Review), cross-functional collaboration, and proactive risk-based guidance in response to evolving regulatory expectations. Required qualifications include a bachelor’s degree in Life Sciences and 8+ years in relevant GxP roles; preferred advanced degrees. The role supports hybrid work arrangements with potential on-site participation and emphasizes strong communication and stakeholder engagement.