Sr. Director, Regulatory Affairs Study Start Up (level dependent on experience)

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. Director, Regulatory Affairs Study Start Up (level dependent on experience) based in the United States. The Sr. Director, Regulatory Affairs Study Start-Up will provide strategic and operational leadership for a global regulatory affairs organization supporting clinical research programs. This senior leadership role oversees organizational performance, regulatory compliance, operational delivery, financial results, and workforce development across geographically dispersed teams. You will establish global standards, strengthen quality governance, and ensure consistent execution of study start-up activities across regions. Partnering with executive leadership, Finance, Commercial, and Clinical Operations, you will align departmental strategy with sponsor expectations and corporate objectives. You will also drive process harmonization, technology adoption, and continuous improvement to enhance efficiency, quality, and scalability. This opportunity is suited to an experienced clinical research leader who thrives in a complex global environment and can balance strategic vision with operational accountability. Accountabilities: The Sr. Director will lead the global Regulatory Affairs Study Start-Up (RASSU) function, ensuring effective organizational leadership, strong regulatory governance, financial accountability, and high-quality delivery aligned with sponsor commitments. - Lead a large, geographically distributed global organization through regional and functional leaders, ensuring appropriate organizational structures, effective spans of control, and consistent execution across regions.

- Define departmental strategy, objectives, performance expectations, and accountability measures aligned with corporate priorities, regulatory requirements, and sponsor commitments. - Maintain accountability for team delivery, productivity, quality, engagement, retention, and achievement of operational and financial targets. - Oversee workforce planning, capacity management, organizational design, succession planning, talent development, and performance management. - Recruit, develop, coach, and retain high-performing leaders and team members while establishing clear expectations for individual and team performance. - Own departmental budgeting, forecasting, headcount planning, operating expenses, and functional investments. - Establish and oversee productivity measures, unit tracking, resource utilization, financial reporting, and operational performance indicators. - Monitor financial and operational results, identify performance variances and emerging risks, and implement corrective actions to improve efficiency, predictability, and profitability. - Partner with Finance, Commercial, and Operations leadership on pricing assumptions, bid development, scope management, and out-of-scope activities. - Serve as the functional owner or subject-matter authority for applicable policies, Global Standard Operating Procedures (GSOPs), work instructions, templates, and supporting tools. - Lead the drafting, review, approval, implementation, training, and periodic revision of controlled documents related to Regulatory Affairs Study Start-Up. - Ensure departmental procedures and activities comply with applicable regulations, ICH-GCP requirements, local requirements, and internal quality standards. - Oversee the timely resolution of audit and inspection findings, corrective and preventive actions, quality events, and identified process gaps. - Define and monitor departmental key performance indicators, quality measures, cycle times, productivity metrics, and financial indicators; analyze trends and implement targeted improvement plans.