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

United StatesRemoteFull-timesenior

Legal & ComplianceRegulatory

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Overview

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,

Technical Tools

Legal & ComplianceRegulatory

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.

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.
Drive global process harmonization, technology adoption, automation, and continuous improvement to enhance quality, operational efficiency, scalability, and the sponsor experience.
Represent the organization in sponsor engagements, governance forums, business development activities, Clinical Operations presentations, and bid proposal reviews.

Requirements

~2 min read

The ideal candidate will bring extensive clinical research experience, a proven record of leading large global teams, and strong expertise in regulatory affairs and study start-up operations. They will combine strategic leadership with financial and operational management capabilities, while building effective relationships across commercial, operational, and functional teams.

At least 15 years of experience in a contract research organization (CRO), pharmaceutical company, biotechnology company, or related clinical research environment, including progressive leadership responsibility for complex global Regulatory Affairs and study start-up activities.
Master's or doctoral degree in a health-related discipline, or an equivalent combination of education and experience as determined by management and Human Resources.
Demonstrated experience leading a large, geographically dispersed global organization through regional or functional leaders, with accountability for team performance, capacity, quality, and delivery.
Proven experience managing departmental budgets, forecasts, productivity or unit tracking, resource utilization, and operational and financial performance metrics.
Experience leading global organizational transformation, process harmonization, technology implementation, or automation initiatives.
Experience supporting commercial strategy, pricing, bid development, scope management, or sponsor governance within a CRO or related environment.
Strong understanding of regulatory compliance, clinical research operations, study start-up processes, and applicable industry requirements.
Demonstrated ability to establish clear performance expectations, develop leadership talent, manage succession planning, and promote engagement and retention across global teams.
Strong financial and analytical capabilities, including the ability to interpret performance trends, identify risks, and implement corrective measures.
Excellent communication, stakeholder management, and influencing skills, with the ability to collaborate effectively across regions, functions, and seniority levels.
Ability to balance strategic priorities with operational execution while maintaining high standards of quality, compliance, and sponsor service.