Manager, Regulatory Affairs Study Start Up (level dependent on experience)

CTI Clinical Trial and Consulting Services•Raleigh, NC

8d•Hybrid

About The Position

The Regulatory Affairs Study Start-Up Manager provides line management, coaching, and professional development for Regulatory Specialists and Regulatory Coordinators while overseeing the delivery and quality of regulatory and study start-up activities across multiple studies and countries. This role provides regional oversight, supports central and local submission strategies, manages regulatory timelines and risks, and partners with sponsors and cross-functional teams to ensure compliant, timely, and inspection-ready study execution. This position will be office based at either our headquarters located in Covington, KY or our office in Raleigh, NC.

Requirements

Bachelor’s Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experience
At least 10 years pharmaceutical or CRO Clinical Regulatory experience
Strong working knowledge and understanding EU regulations, Good Clinical Practice (GCP) International Council for Harmonization (ICH) regulation and guidelines
Demonstrated knowledge of and experience with central and local regulatory and ethics submission processes in the United States and Canada; experience across Latin America is also preferred
Experience providing regional oversight of regulatory and study start-up activities, including coordination across countries, management of submission strategies and timelines, identification and escalation of risks, and alignment with sponsors and cross-functional stakeholders

Responsibilities

Provide day-to-day line management for assigned direct reports, including objective setting, workload oversight, regular one-to-one meetings, performance reviews, and timely performance feedback
Coach and mentor team members to strengthen technical and leadership capabilities, support professional development and career progression, and promote engagement, accountability, and succession readiness
Oversee regulatory document processes and study-specific regulatory timelines; monitor progress and compliance with applicable procedures, identify emerging issues, and implement corrective or alternative solutions as needed
Assess study-specific regulatory resource needs, establish appropriate teams aligned with study goals, and monitor staffing requirements and performance throughout study delivery
Ensure regulatory milestones are achieved and study maintenance activities are completed appropriately throughout all stages of study conduct
Coordinate additional support for studies with critical timelines and ensure appropriate coverage during planned or unexpected staff absences
Contribute regulatory expertise to new business development proposals and participate in bid defenses and capability meetings
Provide education and training to support current understanding of International Council for Harmonisation (ICH) guidelines, Good Clinical Practice (GCP), and other applicable regulatory requirements
Maintain current knowledge of national and international regulatory requirements, guidance, and industry practices, and assess their impact on study-start-up activities
Represent Regulatory Affairs in internal and external study meetings and communicate clear, timely status updates, risks, and recommended actions
Plan and lead internal regulatory team meetings to align priorities, address risks, and drive timely decision-making
Monitor study start-up (SSU) and electronic trial master file (eTMF) status across active studies and ensure records remain current, complete, and inspection-ready
Oversee quality reviews of SSU and eTMF content to confirm accurate naming, filing, and completeness of regulatory documentation
Perform or oversee quality control (QC) and quality assurance (QA) reviews of study-related regulatory documents and reports
Develop and update standard operating procedures (SOPs) as needs are identified, and lead continuous improvement of regulatory processes and supporting procedures
Provide hands-on Regulatory Specialist support when required by business priorities and available resources